MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-08-27 for K-Y TOUCH 2 IN 1 MASSAGE CREME AND PLEASURE GEL manufactured by Reckitt Benckiser Healthcare Int. Limited.
[118388181]
Rb is awaiting the return of the product for quality analysis and also follow up information regarding the reported incident. Reporter did specify the variety of k-y that was used as k-y touch 2 in 1 massage creme and pleasure gel. The reporter neither provided the batch details for the product nor returned any of the remaining unopened product for quality analysis. Further information is expected. The company's assessment is serious with a relatedness of possible.
Patient Sequence No: 1, Text Type: N, H10
[118388182]
Extreme allergic reaction [hypersensitivity] patient had hard time with breathing. [dyspnoea] slight skin rash [rash]. Coughing [cough]. Phlegm in lungs [productive cough]. Case description: initial report, received date: 14-aug-2018. Received from consumer relations, country: united states, reference no: (b)(4). Medical device: k-y touch 2 in 1 massage creme and pleasure gel. Case reference number us-(b)(6) is a spontaneous case report sent by a consumer which refers to a male age unknown. It was reported by patient's partner that on an unknown date, their husband of an unknown age used k-y touch 2 in 1 massage creme and pleasure gel for an unknown indication. Reporter stated that they recently purchased the product and on an unknown date, patient had an extreme allergic reaction with hard time breathing, coughing, phlegm in his lungs and slight skin rash after using the product. The case was deemed serious because it was classed as medically significant. Follow up has been requested to obtain further information. The company's assessment is serious with a relatedness of possible and unanticipated. Case outcome: unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010164364-2018-00008 |
| MDR Report Key | 7820426 |
| Report Source | CONSUMER |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-27 |
| Date Mfgr Received | 2018-08-14 |
| Date Added to Maude | 2018-08-27 |
| 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 | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOANNE MARTINEZ |
| Manufacturer Street | DANSOM LANE |
| Manufacturer City | HULL, HULL,HU8 |
| Manufacturer Country | UK |
| Manufacturer Postal | HULL, HU8 |
| Manufacturer G1 | RECKITT BENCKISER HEALTHCARE INT. LIMITED |
| Manufacturer Street | DANSOM LANE |
| Manufacturer City | HULL, HU8 7DS |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU8 7DS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-Y TOUCH 2 IN 1 MASSAGE CREME AND PLEASURE GEL |
| Generic Name | PERSONAL LUBRICANT |
| Product Code | NUC |
| Date Received | 2018-08-27 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RECKITT BENCKISER HEALTHCARE INT. LIMITED |
| Manufacturer Address | DANSOM LANE HULL, HU8 7DS UK HU8 7DS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-27 |