MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-09-25 for BENGAY MOIST HEAT THERAPY manufactured by Johnson And Johnson Group Of Consumer Companies.
[1178964]
This was a spontaneous report from a (b)(6) female consumer reporting on herself. The consumer reported applying one bengay moist heat therapy pad (no active ingredient) once for five hours on (b)(6)-2009 to relieve a muscle cramp. When she removed the product, it peeled her skin and left a "nickel-sized blister" on her leg. As treatment, the consumer applied neosporin ointment (polymyxin b sulfate, bacitracin zinc, neomycin) and covered the blister with a bandage. As of (b)(6)-2009, the outcome of the event was not resolved. This case is serious (medically significant).
Patient Sequence No: 1, Text Type: D, B5
[8477520]
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 | 2246407-2009-00016 |
| MDR Report Key | 1487635 |
| Report Source | 04 |
| Date Received | 2009-09-25 |
| Date of Report | 2009-09-17 |
| Date of Event | 2009-09-16 |
| Date Mfgr Received | 2009-09-17 |
| 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 (PRINTING UNIT) |
| 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 | PACK, HOT OR COLD, DISPOSABLE |
| Product Code | OMW |
| Date Received | 2009-09-25 |
| Lot Number | 0649CR |
| Device Expiration Date | 2010-06-30 |
| 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. Required No Informationntervention | 2009-09-25 |