MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-06-19 for BENGAY MOIST HEAT THERAPY manufactured by Johnson And Johnson Group Of Consumer Companies.
[1271047]
This was an spontaneous report from a (b)(6), female, consumer, reporting on herself. The consumer reported using one pad of bengay moist heat therapy (no active ingredient) 7 to 8 hours beginning on (b)(6) 2009 for pain in shoulder. On (b)(6) 2009, consumer reported a chemical burn on her shoulder. She also mentioned that when she removed the product from application site, it took her skin off and had bleeding. As treatment, consumer used antibiotic ointment and a band aid. Product was discontinued on (b)(6) 2009 and the outcome of the events was reported as not resolved. This case is serious (medically significant).
Patient Sequence No: 1, Text Type: D, B5
[8432426]
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 | 2246407-2009-00009 |
| MDR Report Key | 1406539 |
| Report Source | 04 |
| Date Received | 2009-06-19 |
| Date of Report | 2009-06-10 |
| Date of Event | 2009-06-05 |
| Date Mfgr Received | 2009-06-10 |
| Date Added to Maude | 2011-03-30 |
| 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 | 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 | 2009-06-19 |
| 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 | 2009-06-19 |