MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-06-12 for BIAFINE TOPICAL EMULSION manufactured by Valeant Usa.
[3546468]
This spontaneous case was received on (b)(4) 2013 from a physician and concerns an unk male pt. The pt's alleged medical history included allergies to avocado and tomato. Concomitant medication were not reported. On an unk date, the pt started treatment with biafine for wound healing. The batch number used was not reported. On an unk date, the pt experienced an allergic reaction and was hospitalized. The outcome of the event was unk. The reporter did not have pt's chart and was not able to provide any additional details, including dates of biafine therapy, hospitalization course, medical history, etc. The physician did not provide a causality assessment. For ref purposes only, this case has also been assigned the following tracking numbers: (b)(4) ((b)(4) on behalf of valeant).
Patient Sequence No: 1, Text Type: D, B5
[10841181]
Pharmacovigilance comment: (b)(4) 2013, allergic reaction assessed as serious and possibly related.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009443653-2013-00109 |
| MDR Report Key | 3170564 |
| Report Source | 05 |
| Date Received | 2013-06-12 |
| Date of Report | 2013-05-24 |
| Date Mfgr Received | 2013-05-24 |
| Date Added to Maude | 2013-06-17 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 700 US RT. 202/206 N |
| Manufacturer City | BRIDGEWATER NJ 08807 |
| Manufacturer Country | US |
| Manufacturer Postal | 08807 |
| Manufacturer Phone | 628566511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIAFINE TOPICAL EMULSION |
| Generic Name | DRESSING, WOUND, HYDROPHILIC |
| Product Code | MGQ |
| Date Received | 2013-06-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VALEANT USA |
| Manufacturer Address | BRIDGEWATER NJ 08807 US 08807 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-06-12 |