MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-08-04 for K-Y TOUCH MASSAGE 2 IN 1 WARMING USA 8004009133 manufactured by Skillman Contract.
[1998859]
Consumer reports that she experienced swelling of her throat and tongue, itching and hives after the second application of this product. Consumer was taken to the hospital by ambulance. She was administered cpr and admitted to the icu once her breathing returned to normal. In the hospital she was treated with hydrocortisone, steroids, epinephrine, and unspecified breathing treatments. The first time she used this product ((b)(6) 2010) she experienced a mild reaction and was treated at in the emergency department.
Patient Sequence No: 1, Text Type: D, B5
[9219891]
Date of this submission is (b)(6) 2011. This closes out this report unless additional significant info is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2214133-2011-00003 |
| MDR Report Key | 2197005 |
| Report Source | 04 |
| Date Received | 2011-08-04 |
| Date of Report | 2011-07-07 |
| Date of Event | 2011-07-06 |
| Date Mfgr Received | 2011-07-07 |
| Date Added to Maude | 2011-08-16 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BRAD LAMOTTE |
| Manufacturer Street | 185 TABOR RD |
| Manufacturer City | MORRIS PLAINS NJ 07950 |
| Manufacturer Country | US |
| Manufacturer Postal | 07950 |
| Manufacturer Phone | 9733853667 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-Y TOUCH MASSAGE 2 IN 1 WARMING USA |
| Generic Name | PERSONAL LUBRICANT |
| Product Code | MMS |
| Date Received | 2011-08-04 |
| Model Number | 8004009133 |
| Lot Number | 0070C |
| Device Expiration Date | 2011-02-12 |
| 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 RD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2011-08-04 |