BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIAFINE TOPICAL EMULSION

    MDR report key: 3170564 · Received June 12, 2013

    Report

    Report Number
    3009443653-2013-00109
    Event Type
    Injury
    Date Received
    June 12, 2013
    Report Date
    May 24, 2013
    Manufacturer
    VALEANT USA
    Product Code
    MGQ
    PMA / PMN Number
    K964240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: (B)(4) 2013, ALLERGIC REACTION ASSESSED AS SERIOUS AND POSSIBLY RELATED.

    Description of Event or Problem · 1

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265024 BIAFINE TOPICAL EMULSION DRESSING, WOUND, HYDROPHILIC MGQ VALEANT USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization