MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-04-21 for BIAFINE manufactured by Johnson And Johnson Group Of Consumer Companies.
[2752230]
This was a regulatory authority report received on (b)(6) 2010, from the (b)(6). A (b)(6) female pt applied an unspecified amount of biafine (trolamine) daily since (b)(6) 2009 (exact therapy date and indication unspecified). In (b)(6) 2009 (date unspecified), she was hospitalized because she had an erythemato-phlyctenular rash on her upper limb which had been progressing since (b)(6) 2009 (exact onset date unspecified). The rash looked photoexposed with a progressive extension. On an unspecified date, a cutaneous biopsy revealed epidermic necrosis with the beginning of detachment compatible with a toxic reaction. Product use was discontinued on (b)(6) 2009 and the event resolved on an unspecified date. This case is serious (hospitalization).
Patient Sequence No: 1, Text Type: D, B5
[9837757]
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 casual association with the device is possible.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243656-2010-00003 |
| MDR Report Key | 2560024 |
| Report Source | 01,05 |
| Date Received | 2010-04-21 |
| Date of Report | 2010-04-12 |
| Date of Event | 2009-07-01 |
| Date Mfgr Received | 2010-04-12 |
| Date Added to Maude | 2012-05-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | BIAFINE |
| Generic Name | DRESSING, WOUND AND BURN, OCCLUSIVE |
| Product Code | MGQ |
| Date Received | 2010-04-21 |
| 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. Hospitalization; 2. Deathisabilit | 2010-04-21 |