MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-08-31 for BENGAY MOIST HEAT THERAPY manufactured by Johnson And Johnson Group Of Consumer Companies.
[1473718]
This report contains both initial and additional info received on (b)(6) 2010 and (b)(6) 2010 respectively. This was a spontaneous report received from a (b)(6) female consumer reporting on herself. The consumer used two bengay moist heat therapy pads (no active ingredient) daily during the day time beginning on (b)(6) 2010 for pain and bengay pain relief and massage (menthol) nightly beginning on (b)(6) 2010 for pain. On (b)(6) 2010, her skin burnt to a few levels inside of the skin, she had water boils from her head to feet describes as chickenpox, she was unable to walk for a week, and she was in pain because her whole skin was burned. On an unk date, she went to the physician who prescribed an unspecified medication. On unk dates, she lost a week of work. On (b)(6) 2010, use of both products was discontinued. As of (b)(6) 2010, the outcome of the events was reported as not resolved.
Patient Sequence No: 1, Text Type: D, B5
[8702426]
At this time, the device has not been returned for failure analysis / laboratory testing. Therefore, no causal association or conclusion can be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2246407-2010-00003 |
| MDR Report Key | 1837378 |
| Report Source | 04 |
| Date Received | 2010-08-31 |
| Date of Report | 2010-08-23 |
| Date of Event | 2010-07-22 |
| Date Mfgr Received | 2010-08-23 |
| Date Added to Maude | 2011-03-17 |
| 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 RD |
| Manufacturer City | MORRIS PLAINS NJ 07950 |
| Manufacturer Country | US |
| Manufacturer Postal | 07950 |
| Manufacturer Phone | 2153257685 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BENGAY MOIST HEAT THERAPY |
| Generic Name | PACK, HOT OR COLD, DISPOSABLE |
| Product Code | OMW |
| Date Received | 2010-08-31 |
| 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 | 2010-08-31 |