BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIAFINE

    MDR report key: 2609701 · Received November 11, 2009

    Report

    Report Number
    2243656-2009-00003
    Event Type
    Other
    Date Received
    November 11, 2009
    Date of Event
    October 1, 2009
    Report Date
    October 19, 2009
    Manufacturer
    JOHNSON AND JOHNSON GROUP OF CONSUMER COMPAINIES
    Product Code
    MGQ
    PMA / PMN Number
    BIA---EM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE DEVICE HAS NOT BEEN RETURNED FOR FAILURE ANALYSIS/LAB TESTING. GIVEN THE CIRCUMSTANCES OF THE REPORTED EVENT(S) AND THE KNOWN MECHANISM OF ACTION OF THE DEVICE, A CAUSAL ASSOCIATION WITH THE DEVICE IS POSSIBLE.

    Description of Event or Problem · 1

    THIS WAS A SPONTANEOUS REPORT FROM A (B)(6) MALE CONSUMER REPORTING ON HIMSELF. THE CONSUMER APPLIED AN UNSPECIFIED AMOUNT OF BIAFINE (NO ACTIVE INGREDIENT) ON (B)(6) 2009 TO BOTH ARMS AS DIRECTED BY A HEALTH CARE PROFESSIONAL FOR WOUND HEALING. ON AN UNSPECIFIED DATE, HE DEVELOPED SWELLING AND HIVES ON BOTH ARMS ALONG WITH DIFFICULTY BREATHING AFTER TOUCHING HIS FACE WITH HIS HANDS. HE THEN CONSULTED WITH HIS HEALTH CARE PROFESSIONAL WHO DISCONTINUED PRODUCT USE AND PRESCRIBED BENADRYL (COMPANY DRUG) AND XYZAL (NON-COMPANY DRUG) AS TREATMENT. A FEW DAYS LATER, THE SYMPTOMS PROGRESSED AND HE THEN WENT TO THE ER WHERE HE WAS PRESCRIBED PREDNISONE (NON-COMPANY DRUG) AS TREATMENT. PRODUCT USE WAS DISCONTINUED ON (B)(6) 2009 AND THE OUTCOME OF THE EVENTS WAS REPORTED AS RECOVERING (DATE UNSPECIFIED). THIS CASE IS SERIOUS (MEDICALLY SIGNIFICANT). BIAFINE CASE IS LINKED TO BENADRYL CASE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIAFINE DRESSING, WOUND AND BURN, OCCLUSIVE MGQ JOHNSON AND JOHNSON GROUP OF CONSUMER COMPAINIES

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| O