MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-04-07 for BENGAY MOIST HEAT THERAPY manufactured by Johnson And Johnson Group Of Consumer Companies.
[17019123]
A (b) (6) female consumer applied 1 bengay moist heat therapy odorless patch (no active ingredient) once on (b) (6) 2008 for stomach cramps. Five hours after product use on (b) (6) 2008, she had 5 painful, raised blisters that were inflamed, and puss filled on her belly. The consumer also reported that 2 of the blisters looked like they would leave some scars on her belly. She self-treated the events with neosporin (bacitracin/neomycin/polymyxin) (dose, frequency and treatment date unspecified); and with advil (ibuprofen) for pain. Product use was discontinued on (b) (6) 2008. As of (b) (6) 2008, the outcome of the events was reported as not resolved.
Patient Sequence No: 1, Text Type: D, B5
[17242285]
The product was not returned for failure analysis/lab 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 | 2246407-2008-00004 |
| MDR Report Key | 1026125 |
| Report Source | 04 |
| Date Received | 2008-04-07 |
| Date of Report | 2008-03-31 |
| Date of Event | 2008-03-29 |
| Date Mfgr Received | 2008-03-31 |
| Date Added to Maude | 2010-03-27 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 201 TABOR ROAD |
| Manufacturer City | MORRIS PLAINS NJ 07950 |
| Manufacturer Country | US |
| Manufacturer Postal | 07950 |
| Manufacturer Phone | 9733850704 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BENGAY MOIST HEAT THERAPY |
| Generic Name | NONE |
| Product Code | OMW |
| Date Received | 2008-04-07 |
| Lot Number | A7X1 |
| Device Expiration Date | 2009-09-01 |
| 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 | 2008-04-07 |