MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-05-22 for BENGAY MOIST HEAT THERAPY manufactured by Johnson And Johnson Group Of Consumer Companies.
[1266248]
This was a spontaneous report from a male consumer reporting on himself. The consumer reported applying bengay moist heat therapy pad (no active ingredient) dose, frequency, dates, and indication unspecified). As the consumer removed the product from his right ankle (date unspecified), his "skin came off with it. " also, he was in pain and discomfort and could hardly walk or wear his shoes. On an unspecified date, he visited a hospital and was advised to apply an antibiotic cream and keep the area covered as treatment. He thought that the product's batch "must be 300% stronger". On an unspecified date, product use was discontinued. As of (b) (6) 2009, the outcome of the events was not resolved. This case is serious (medically significant, required intervention).
Patient Sequence No: 1, Text Type: D, B5
[8356074]
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 | 2246407-2009-00007 |
MDR Report Key | 1420460 |
Report Source | 04 |
Date Received | 2009-05-22 |
Date of Report | 2009-05-11 |
Date Mfgr Received | 2009-05-11 |
Date Added to Maude | 2010-03-25 |
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 | 2009-05-22 |
Lot Number | A8P6 |
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; 2. Required No Informationntervention | 2009-05-22 |