MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-07-13 for BENGAY MOIST HEAT THERAPY manufactured by Johnson And Johnson Group Of Consumer Companies.
[1265183]
This was a spontaneous report from a (b) (6) female consumer reporting on herself. The consumer reported that she used three patches of bengay moist heat therapy (no active ingredient) where one patch was applied for five hours and two were applied for four hours beginning on (b) (6)-2009 for a back problem along the left side and problems with her hip and leg on the other side. On (b) (6)-2009, consumer reported that she was severely burnt on her hip and leg a short time after product use. Also, she mentioned that she was in a lot of pain. The consumer treated the events with neosporin cream and dial soap. On (b) (6)-2009, product use was discontinued. As of (b) (6)-2009, the outcome of the events was reported as not resolved. This case is serious (medically significant).
Patient Sequence No: 1, Text Type: D, B5
[8282643]
The product was not returned for failure analysis/laboratory testing. It cannot be ruled out that the product may have possibly caused the event. See scanned page.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2246407-2009-00010 |
| MDR Report Key | 1463175 |
| Report Source | 04 |
| Date Received | 2009-07-13 |
| Date of Report | 2009-07-07 |
| Date of Event | 2009-06-29 |
| Date Mfgr Received | 2009-07-07 |
| Date Added to Maude | 2010-07-29 |
| 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 ROAD |
| 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 | 2009-07-13 |
| 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 | 2009-07-13 |