BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTICOAT ABSORBENT 10X12.5CM 5/BX

    MDR report key: 4886481 · Received July 2, 2015

    Report

    Report Number
    8043484-2015-00086
    Event Type
    Injury
    Date Received
    July 2, 2015
    Date of Event
    October 15, 2013
    Report Date
    October 15, 2013
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD A REACTION TO ACTICOAT ABSORBENT. ACTICOAT ABSORBENT DRESSING WAS PLACED ONTO A LEG ULCER WOUND, ON TOP OF A NON-ADHERENT VASELINE TYPE DRESSING. WITHIN 30 MINUTES THE PATIENT WAS IN EXTREME PAIN, WITH A SEVERE BURNING SENSATION. DRESSING WAS REMOVED IMMEDIATELY SHOWING THE WOUND TO BE BRIGHT RED. SKIN SURROUNDING THE AREA WAS ALSO RED WITH BUMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431831 ACTICOAT ABSORBENT 10X12.5CM 5/BX DRESSING, WOUND, DRUG FRO SMITH & NEPHEW MEDICAL LTD. 20381 1313

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention