MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-25 for BIAFINE TOPICAL EMULSION manufactured by Valeant Pharmaceuticals International.
[39086051]
The product was not returned and the lot number was not reported. The consumer reported the product was prescribed for an existing infection and that he did not develop an infection from the product. Based on all information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[39086052]
It was reported a patient used the product as treatment by applying it to his middle toe once daily and covered for 24 hours. The patient developed an unspecified infection four days after starting the product. The patient was hospitalized and treated with unspecified iv antibiotics. Six days later while in the hospital, the patient developed gangrene and his middle toe was amputated. The patient was discharged four days later with unspecified iv antibiotics. The patient's wound has healed. Upon follow-up with the patient, he reported the product was prescribed for an existing infection and that he did not develop an infection from the product. Medical documentation has been requested but not received.
Patient Sequence No: 1, Text Type: D, B5
[41949365]
Follow-up report submitted to provide correct information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009443653-2016-00003 |
| MDR Report Key | 5461846 |
| Date Received | 2016-02-25 |
| Date of Report | 2016-02-01 |
| Date of Event | 2015-12-01 |
| Date Mfgr Received | 2016-02-01 |
| Date Added to Maude | 2016-02-25 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SHARON SPENCER |
| Manufacturer Street | 50 TECHNOLOGY DRIVE WEST |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9493985698 |
| Manufacturer G1 | JOHNSON & JOHNSON FRANCE VAL DE REUIL |
| Manufacturer Street | CAMPUS DE MAIGREMONT BP615 27106 VAL DE REUIL CEDEX |
| Manufacturer City | FRANCE |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIAFINE TOPICAL EMULSION |
| Generic Name | DRESSING,WOUND & BURN,HYDROGEL W/DRUG &/OR BIOLOGI |
| Product Code | MGQ |
| Date Received | 2016-02-25 |
| ID Number | NI |
| 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 | VALEANT PHARMACEUTICALS INTERNATIONAL |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit | 2016-02-25 |