MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-05-15 for BENGAY MOIST HEAT THERAPY manufactured by Johnson And Johnson Group Of Consumer Companies.
[1199382]
This was a spontaneous self-report received from male consumer. The consumer used 1 patch of bengay moist heat therapy pad (no active ingredient) once in 2009, for leg pain. He left it on all night and got up next morning. The next day, the product left a welt on his thigh were the product was applied. It was about 3 inches in size, and red, ugly, and burning. The events were treated with neosporin. Product use was discontinued the following day. As 2009, the events did not resolved. This case is non-serious (medically significant). This case has been reassessed as serious based upon additional information received the following month. The consumer reported that the welt on his leg which caused by the product was not going away. This case is serious (medically significant, permanent damage).
Patient Sequence No: 1, Text Type: D, B5
[8331914]
The product was not returned for failure analysis/laboratory testing. It cannot be ruled out that the product may have possibly caused the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2246407-2009-00008 |
| MDR Report Key | 1387656 |
| Report Source | 04 |
| Date Received | 2009-05-15 |
| Date of Report | 2009-04-27 |
| Date of Event | 2009-04-26 |
| Date Mfgr Received | 2009-05-12 |
| Date Added to Maude | 2009-05-26 |
| 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 | 0 |
| Manufacturer Street | 185 TABOR ROAD |
| Manufacturer City | MORRIS PLAINS NJ 07950 |
| Manufacturer Country | US |
| Manufacturer Postal | 07950 |
| Manufacturer Phone | 9733852990 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BENGAY MOIST HEAT THERAPY |
| Generic Name | PAD, MEDICATED, ADHESIVE, NON-ELECTRIC |
| Product Code | OMW |
| Date Received | 2009-05-15 |
| 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 | JOHNSON AND JOHNSON GROUP OF CONSUMER COMPANIES |
| Manufacturer Address | MORRIS PLAINS NJ 07950 US 07950 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2009-05-15 |