BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIAFINE (US)

    MDR report key: 2196875 · Received August 4, 2011

    Report

    Report Number
    3002707994-2011-00387
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    June 22, 2011
    Report Date
    August 4, 2011
    Manufacturer
    JOHNSON & JOHNSON CONSUMER COMPANIES, INC
    Product Code
    MGQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS WAS A SPONTANEOUS REPORT FROM A HEALTH PROFESSIONAL, VIA A REGULATORY AUTHORITY (B)(6), AND CONCERNS A (B)(6) FEMALE FROM (B)(6). THE PT'S HEIGHT, WEIGHT AND MEDICAL HISTORY WERE UNSPECIFIED. THE PT WAS TREATED WITH TROLAMINE (EMULSION, TOPICAL) INITIATED ON (B)(6) 2011 TO (B)(6) 2011 FOR REDNESS AFTER BEING OUT IN THE MOUNTAINS. CONCOMITANT MEDICATIONS INCLUDED LOGIFLOX (LOMEFLOXACIN) (TABLET, ORAL) TWO TABLETS ON (B)(6) 2011 AND ONE TABLET ON (B)(6) 2011 FOR AN UNSPECIFIED INDICATION. ON (B)(6) 2011, THE PT EXPERIENCED BURNS AT 1ST AND 2ND DEGREES ON THE ARMS, LEGS AND UPPER SIDE OF THE BODY. THE PT WENT TO THE EMERGENCY UNIT ON (B)(6) 2011 AND WAS ADMITTED TO THE HOSPITAL THAT SAME DAY (DISCHARGE DATE UNSPECIFIED). TREATMENT WAS NOT SPECIFIED. ACTION TAKEN WITH TROLAMINE WAS WITHDRAWN. AT THE TIME OF THE REPORTING, THE OUTCOME FOR BURN WAS UNSPECIFIED. THIS CASE IS LINKED TO DRUG/DEVICE CASE (B)(4). THIS REPORT WAS SERIOUS (HOSPITALIZATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIAFINE (US) NONE MGQ JOHNSON & JOHNSON CONSUMER COMPANIES, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization