MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-05-15 for BENGAY MOIST HEAT THERAPY manufactured by Johnson And Johnson Group Of Consumer Companies.
[1194408]
This was a spontaneous report from a female consumer reporting on herself. The consumer reported applying one bengay moist heat therapy pad (no active ingredient) once daily as needed beginning 2009 for minor aches and pains. After application the following month, the consumer's face was swollen. She reported that she has a history of asthma and environmental and medication allergies, and stated that she may have touched her face after handling the product. On the same date, she visited a physician who prescribed steroids and gave her an injection of benadryl (diphendydramine). Product use was discontinued the same day. As of the date of her report, the next day, the outcome of the event was not resolved. This case is serious (medically significant).
Patient Sequence No: 1, Text Type: D, B5
[8147235]
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 | 2246407-2009-00006 |
| MDR Report Key | 1387655 |
| Report Source | 04 |
| Date Received | 2009-05-15 |
| Date of Report | 2009-05-08 |
| Date of Event | 2009-05-07 |
| Date Mfgr Received | 2009-05-08 |
| Date Added to Maude | 2009-05-26 |
| 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 | 2009-05-15 |
| Lot Number | ASPT |
| Device Expiration Date | 2010-01-31 |
| 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 | 2009-05-15 |