MAUDE Adverse Event Report: VALEANT PHARMACEUTICALS INTERNATIONAL BIAFINE TOPICAL EMULSION; DRESSING,WOUND & BURN,HYDROGEL W/DRUG &/OR BIOLOGI

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Gangrene (1873); Unspecified Infection (1930); Deformity/ Disfigurement (2360); Post Traumatic Wound Infection (2447)

Event Date 12/01/2015

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

Follow-up report submitted to provide correct information.

• Brand Name: BIAFINE TOPICAL EMULSION
• Type of Device: DRESSING,WOUND & BURN,HYDROGEL W/DRUG &/OR BIOLOGI
• Manufacturer (Section D): VALEANT PHARMACEUTICALS INTERNATIONAL; rochester NY 14609
• Manufacturer (Section G): JOHNSON & JOHNSON FRANCE VAL DE REUIL; campus de maigremont bp615; 27106 val de reuil cedex; france ; FR
• Manufacturer Contact: sharon spencer ; 50 technology drive west; irvine, CA 92618 ; 9493985698
• MDR Report Key: 5461846
• MDR Text Key: 39086051
• Report Number: 3009443653-2016-00003
• Device Sequence Number: 1
• Product Code: MGQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 55 YR