MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-07-15 for BENGAY MOIST HEAT THERAPY manufactured by Johnson And Johnson Group Of Consumer Companies.
[1103372]
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 on (b)(6)-2009 to hip to relieve her arthritic pain. After 5-6 hours of administration sitting in a chair, she had a seeping burn on her hip, with large blisters. On unspecified dates, the consumer visited her physician three times. As treatment, she used neosporin (bacitracin zinc, neomycin, polymyxin b sulphate), sulfadiazine silver cream (non-company drug) twice daily for two weeks, duoderm tape (non-company drug) once every two days, and applied bandages. As of (b)(6)-2009, the outcome of the events was not resolved. This case is serious (medically significant).
Patient Sequence No: 1, Text Type: D, B5
[8434186]
The product was not returned for failure analysis/ laboratory testing. It cannot be ruled out that the product may have possible caused the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2246407-2009-00011 |
| MDR Report Key | 1414633 |
| Report Source | 04 |
| Date Received | 2009-07-15 |
| Date of Report | 2009-07-08 |
| Date of Event | 2009-05-27 |
| Date Mfgr Received | 2009-07-08 |
| 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 ROAD 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 | 2009-07-15 |
| Lot Number | 0759CR |
| Device Expiration Date | 2010-04-30 |
| 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 | 2009-07-15 |