MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-01-20 for BENGAY MOIST HEAT THERAPY manufactured by Johnson And Johnson Group Of Consumer Companies.
[1416161]
This was a spontaneous report from a female consumer reporting on herself(age unspecified). The consumer applied one bengay moist heat therapy patch (no active ingredient) on (b)(6) 2009 (frequency of use and indication unspecified). The consumer stated that product did not stick on application site. After taking patch off (date unspecified); it tore her skin off deep and after product use, she could not lie or sit on that side. On an unspecified date, consumer consulted with her physician who prescribed unspecified medication as treatment. Consumer also used hydrogel (non-company drug) with dressing as treatment. As of (b)(6) 2010, both product use and the outcome of the event were unk. This case is serious (medically significant).
Patient Sequence No: 1, Text Type: D, B5
[8344673]
At this time, the device has not been returned for failure analysis/laboratory testing. Given the circumstances of the reported event(s) and the known mechanism of action of the device, a causal association with the device is possible.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2246407-2010-00001 |
| MDR Report Key | 1583374 |
| Report Source | 04 |
| Date Received | 2010-01-20 |
| Date of Report | 2010-01-12 |
| Date of Event | 2009-12-29 |
| Date Mfgr Received | 2010-01-12 |
| 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 | PAD, MEDICATED, ADHESIVE, NON-ELECTRIC |
| Product Code | OMW |
| Date Received | 2010-01-20 |
| Lot Number | A807 |
| Device Expiration Date | 2010-02-28 |
| 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 | 2010-01-20 |