MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-04-10 for K-Y TOUCH MASSAGE 2 IN 1 WARMING KY21WMUS manufactured by Skillman Contract.
[2591021]
This spontaneous report was received on (b)(6) 2012 from a (b)(6) female consumer reporting on self from the united states. The consumer did not have any known medical history. The concomitant medication included loestrin (ethinyl estradiol and norethisterone) once daily for thirty days for birth control. On an unspecified date, the consumer started using k-y yours plus mine which included k-y yours + mine lubricant - yours (lot number 0261dyh and expiration date 30-jun-2013, dose unspecified) and k-y yours + mine lubricant - mine (lot number 0221dmhr and expiration date 30-jun-2012, dose unspecified) both the devices, one application at a time, vaginally for pleasure. She had no reaction. After an unspecified duration, she again used both the devices along with k-y brand touch massage 2-in-1 warming, a teaspoon amount, once, vaginally for pleasure (lot number 0131c, expiration date unspecified). After an unspecified duration, she experienced breathing difficulty with slight wheezing. She did not use the devices k-y yours + mine lubricant - yours and k-y yours + mine lubricant - mine further. After an unspecified duration, on (b)(6) 2012, she used k-y brand touch massage 2-in-1 warming once and on the same day she visited emergency room where she was given unspecified steroids intravenously, fluids and unspecified breathing treatments for anaphylactic reaction. She did not use the device k-y brand touch massage 2-in-1 warming further. She was prescribed steroids by her physician which she did not take. On (b)(6) 2012, the event started to resolve. After an unspecified duration, the event resolved. Batch records were reviewed and no non-conformances or deviations were noted. A review of the data associated with this complaint category (difficulty breathing) revealed no adverse trends and no trend involving the lot numbers of the couple lubricants and the warming massage. Complaint trends would continue to be monitored. This report was assessed as serious (required intervention). The company causality was assessed as possible.
Patient Sequence No: 1, Text Type: D, B5
[2839763]
This spontaneous report was received on (b)(6) 2012 from a (b)(6) female consumer reporting on self from the united states. The consumer did not have any known medical history. The concomitant medication included loestrin (ethinyl estradiol and norethisterone) once daily for thirty days for birth control. On an unspecified date, the consumer started using k-y yours plus mine, which included k-y yours + mine lubricant - yours (lot number 0261dyh and expiration date 30-jun-2013, dose unspecified) and k-y yours + mine lubricant - mine (lot number 0221dmhr and expiration date 30-jun-2012, dose unspecified) both the devices, one application at a time, vaginally for pleasure. She had no reaction. After an unspecified duration, she again used both the devices along with k-y brand touch massage 2-in-1 warming, a teaspoon amount, once, vaginally for pleasure (lot number 0131c, expiration date unspecified). After an unspecified duration, she experienced breathing difficulty with slight wheezing. She did not use the devices k-y yours + mine lubricant - yours and k-y yours + mine lubricant - mine further. After an unspecified duration, on (b)(6) 2012, she used k-y brand touch massage 2-in-1 warming once and on the same day, she visited emergency room where she was given unspecified steroids intravenously, fluids and unspecified breathing treatments for anaphylactic reaction. She did not use the device k-y brand touch massage 2-in-1 warming further. She was prescribed steroids by her physician, which she did not take. On (b)(6) 2012, the event started to resolve. After an unspecified duration, the event resolved. Batch records were reviewed and no non-conformances or deviations were noted. A review of the data associated with this complaint category (difficulty breathing) revealed no adverse trends and no trend involving the lot numbers of the couple lubricants and the warming massage. Complaint trends would continue to be monitored. This report was assessed as serious (required intervention). The company causality was assessed as possible. Additional information received from a physician on (b)(4) 2012. The consumer was diagnosed with allergic reaction. She was advised to take medication as directed, increase oral fluids and follow up with a doctor as needed or if condition worsens. This report remains serious.
Patient Sequence No: 1, Text Type: D, B5
[2949947]
This spontaneous report was received on (b)(6) 2012 from a (b)(6) female consumer reporting on self from the united states. She did not have any known medical history, concomitant medication included loestrin (ethinyl estradiol and norethisterone) once daily for 30 days for birth control. On an unspecified date, she started using k-y yours + mine lubricant - yours (lot number 0261dyh, expiration date 30-jun-2013, dose unspecified) and k-y yours + mine lubricant - mine (lot number 0221dmhr,expiration date 30-jun-2012, dose unspecified) both the devices, one application, vaginally for pleasure. She had no reaction. After an unspecified duration, she again used both the devices along with k-y brand touch massage 2-in-1 warming, a teaspoon amount, once, vaginally for pleasure (lot number 0131c, expiration date unspecified). After an unspecified duration, she experienced breathing difficulty with slight wheezing. She did not use the devices yours and mine further. After an unspecified duration, on (b)(6) 2012, she used touch massage once and on the same day, she visited emergency room where she was given unspecified steroids intravenously, fluids and unspecified breathing treatments for anaphylactic reaction. She did not use the device touch massage further. She was prescribed steroids by her physician which she did not take. On (b)(6) 2012, the event started to resolve. After an unspecified duration, the event resolved. Batch records were reviewed and no non-conformances or deviations were noted. A review of the data associated with this complaint category revealed no adverse trends and no trend involving the lot numbers of the couple lubricants and the warming massage. Complaint trends would continue to be monitored. This report was assessed as serious (required intervention). The company causality was assessed as possible. Additional information received from a physician on (b)(4) -2012: the consumer was diagnosed with allergic reaction. She was advised to take medication as directed, increase oral fluids and follow up with a doctor as needed or if condition worsens. This report remains serious. Additional information received on (b)(4) 2012: the medical history included a rod in femur. She used k-y yours + mine lubricant - yours (lot number 0221dmhr), k-y yours + mine lubricant - mine (lot number 0261dyh) and k-y brand touch massage 2-in-1 warming together on two different occasions and experienced wheezing and breathing difficulty. Both the times the events resolved after an unspecified duration. After an unspecified duration, on (b)(6) 2012, following the use of touch massage, immediately she was unable to breath, had wheezing, continued coughing and also throat and ears were itching. She also felt like electricity and swelling running through her peritoneal region. She took two benadryl (diphenhydramine) and after 45 minutes she was taken to emergency room. The physical examination revealed pulse rate of 100, respiratory rate 18, o2 saturation of 100 percent and blood pressure 156/88 (units and normal ranges unspecified). She was diagnosed with adverse reaction to the sexual lubricant and was treated with saline iv 1 l, solu-medrol (methylprednisolone) 125 mg iv push, pepcid (famotidine) 20 mg iv piggyback (sic), and an unspecified nebulizer 5 mg once in the er. On the next day, she was discharged and prescribed oral prednisone 50 mg daily for 5 days, oral atarax (vistaril) 25 mg four times a day for 7 days, oral zantac (ranitidine) 150 mg twice daily for 7 days. She was advised for follow up with primary care physician in 1 to 2 days, in case of increased shortness of breath and wheeze, and no more sexual activity. However, the consumer stated that, she was not under the physician care and did not take any prescribed medications for allergies. She stated that, in the past, she used k-y yours and k-y mine without touch massage and did not experience any wheezing. This report remains serious (required intervention).
Patient Sequence No: 1, Text Type: D, B5
[9951545]
(b)(4). This closes out this report unless other additional significant information is received. This is an initial submission for the second product in this case. The manufacturer report number for this submission is 2214133-2012-00010. The initial submission for the second product in this case had the manufacturer report number 2214133-2012-00011.
Patient Sequence No: 1, Text Type: N, H10
[10091468]
(b)(4). This closes out this report unless other additional significant information is received. This is a follow up submission for the second product in this case. The manufacturer report number for this submission is 2214133-2012-00011. The follow up submission for the first product in this case had the manufacturer report number 2214133-2012-00010.
Patient Sequence No: 1, Text Type: N, H10
[10242130]
(b)(4). This closes out this report unless other additional significant information is received. This is a follow up submission for the second product in this case. The manufacturer report number for this submission is 2214133-2012-00011. The manufacturer report number for the first product is 2214133-2012-00010.
Patient Sequence No: 1, Text Type: N, H10
[16874516]
This spontaneous report was received on (b)(6) 2012 from a (b)(6) female consumer reporting on self from the united states. She did not have any medical history, concomitant medication included loestrin (ethinyl estradiol and norethisterone)once daily for 30 days for birth control. On an unspecified date, she started using k-y yours + mine lubricant - yours (lot number 0261dyh, expiration date 30-jun-2013, dose unspecified)and k-y yours + mine lubricant - mine (lot number 0221dmhr, expiration date 30-jun-2012, dose unspecified) both the devices, once, vaginally for pleasure. She had no reaction. After an unspecified duration, she again used the devices along with k-y brand touch massage 2-in-1 warming, a teaspoon amount, once, vaginally for pleasure (lot number 0131c, expiration date unspecified). After an unspecified duration, she experienced breathing difficulty with slight wheezing. She did not use the yours and mine further. After an unspecified duration, on (b)(6) 2012, she used touch massage once and on the same day, she visited emergency room where she was given unspecified steroids iv fluids and unspecified breathing treatments for anaphylactic reaction. She did not use the touch massage further. She was prescribed steroids by her physician which she did not take. On (b)(6) 2012, the event started to resolve. After an unspecified duration, the event resolved. Batch records were reviewed and no non-conformances or deviations were noted. A review of the data associated with this complaint category revealed no adverse trends and no trend involving the lot numbers of the couple lubricants and the warming massage. Complaint trends would continue to be monitored. This report was assessed as serious(required intervention). The company causality was assessed as possible. Additional information received from physician on (b)(4) 2012. The consumer was diagnosed with allergic reaction. She was advised to take medication as directed, increase oral fluids and follow up with doctor as needed or if condition worsens. This report remains serious. Additional information received on (b)(4) 2012: the medical history included a rod in femur. She used k-y yours + mine lubricant - yours (lot number 0221dmhr), k-y yours + mine lubricant - mine (lot number 0261dyh) and k-y brand touch massage 2-in-1 warming together on two occasions and experienced wheezing and breathing difficulty. Both times events resolved after an unspecified duration. After an unspecified duration, on (b)(6) 2012, following use of touch massage, immediately she was unable to breath, had wheezing, continued coughing and throat and ears were itching. She also felt like electricity and swelling running through peritoneal region. She took 2 benadryl (diphenhydramine) and after 45 min, she was taken to emergency room. Physical examination revealed pulse rate 100, respiratory rate 18, o2 saturation 100% and bp 156/88 (units and normal ranges unspecified). She was diagnosed with adverse reaction to the sexual lubricant and was treated with saline iv1l,solu-medrol(methylprednisolone) 125 mg iv push,pepcid (famotidine) 20 mg iv piggyback (sic), and unspecified nebulizer 5 mg once in the er. On the next day, she was discharged and prescribed oral prednisone 50 mg daily for 5 days, oral atarax (vistaril) 25 mg four times a day for 7 days, oral zantac (ranitidine) 150 mg twice daily for 7 days. She was advised for follow up with primary care physician in 1 to 2 days, in case of increased shortness of breath and wheeze, and no more sexual activity. However, the consumer stated that she was not under the physician care and did not take any prescribed medications for allergies. She stated that in the past she used yours and mine without touch massage and did not experience any wheezing. This report remains serious (required intervention). Additional information received on (b)(4) 2012. Lot numbers for k-y yours + mine lubricant - yours and k-y yours + mine lubricant - mine were updated to 0261dyh and 0221dmhr. This report remains serious (required intervention).
Patient Sequence No: 1, Text Type: D, B5
[16995569]
(b)(4). This is a follow up submission for the second product in this case. The manufacturer report number for this submission is 2214133-2012-00011. The manufacturer report number for the first product is 2214133-2012-00010. This closes out this report unless other additional significant information is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2214133-2012-00011 |
| MDR Report Key | 2524886 |
| Report Source | 04 |
| Date Received | 2012-04-10 |
| Date of Report | 2012-03-26 |
| Date of Event | 2012-03-17 |
| Date Mfgr Received | 2012-11-07 |
| Date Added to Maude | 2012-04-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MS. AMAL YAMANY |
| Manufacturer Street | 199 GRANDVIEW ROAD NI |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089043455 |
| Manufacturer G1 | SKILLMAN CONTRACT |
| Manufacturer Street | 199 GRANDVIEW ROAD NI |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08558 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-Y TOUCH MASSAGE 2 IN 1 WARMING |
| Generic Name | LUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE |
| Product Code | MMS |
| Date Received | 2012-04-10 |
| Model Number | KY21WMUS |
| Catalog Number | NI |
| Lot Number | 0131C |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SKILLMAN CONTRACT |
| Manufacturer Address | 199 GRANDVIEW ROAD NI SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-04-10 |