MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-06-17 for BENGAY MOIST HEAT THERAPY PADS UNK manufactured by Johnson & Johnson Consumer Companies, Inc.
[18842687]
This was a spontaneous report from a lawyer and concerns a male pt of unspecified age from united states: (b)(4). The pt's height, weight and medical history were unspecified. On (b)(6) 2011, the pt applied bengay moist heat therapy pads to the back of his left leg for an unspecified indication. Concomitant medications were not reported. On (b)(6) 2011, approx half an hour after the product was applied, the pt experienced a searing hot pain on his leg and angry bubbling blisters. He went to the emergency room (er) and was informed, it was a severe chemical burn and skin tear lacerations. It was also reported that the pt had suffered a great deal of pain, permanent disfigurement and distress from the injuries. The action taken with bengay moist heat therapy pads was unspecified. At the time of the reporting, the outcome of the events chemical burn, skin tear, pain, disfigurement, distressed was unspecified. This report was serious (medically significant).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246407-2011-00254 |
| MDR Report Key | 2139204 |
| Report Source | 04 |
| Date Received | 2011-06-17 |
| Date of Report | 2011-06-17 |
| Date of Event | 2011-03-13 |
| Date Mfgr Received | 2011-05-25 |
| Date Added to Maude | 2011-06-28 |
| 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 Street | 199 GRANDVIEW AVE. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 2153257685 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BENGAY MOIST HEAT THERAPY PADS |
| Generic Name | NONE |
| Product Code | OMW |
| Date Received | 2011-06-17 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | A8U0 |
| ID Number | UNK |
| 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 & JOHNSON CONSUMER COMPANIES, INC |
| Manufacturer Address | SKILLMAN NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-06-17 |