MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-11-11 for BIAFINE manufactured by Johnson And Johnson Group Of Consumer Compainies.
[19649512]
At this time, the device has not been returned for failure analysis/lab 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
[19661119]
This was a spontaneous report from a (b)(6) male consumer reporting on himself. The consumer applied an unspecified amount of biafine (no active ingredient) on (b)(6) 2009 to both arms as directed by a health care professional for wound healing. On an unspecified date, he developed swelling and hives on both arms along with difficulty breathing after touching his face with his hands. He then consulted with his health care professional who discontinued product use and prescribed benadryl (company drug) and xyzal (non-company drug) as treatment. A few days later, the symptoms progressed and he then went to the er where he was prescribed prednisone (non-company drug) as treatment. Product use was discontinued on (b)(6) 2009 and the outcome of the events was reported as recovering (date unspecified). This case is serious (medically significant). Biafine case is linked to benadryl case (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243656-2009-00003 |
| MDR Report Key | 2609701 |
| Report Source | 04 |
| Date Received | 2009-11-11 |
| Date of Report | 2009-10-19 |
| Date of Event | 2009-10-01 |
| Date Mfgr Received | 2009-10-19 |
| Date Added to Maude | 2012-06-13 |
| 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 | BIAFINE |
| Generic Name | DRESSING, WOUND AND BURN, OCCLUSIVE |
| Product Code | MGQ |
| Date Received | 2009-11-11 |
| 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 COMPAINIES |
| Manufacturer Address | MORRIS PLAINS NJ 07950 US 07950 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2009-11-11 |