BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER FLEX MED/SELF-ADHERING ELASTIC BANDAGE

    MDR report key: 5700329 · Received June 2, 2016

    Report

    Report Number
    MW5062654
    Event Type
    Malfunction
    Date Received
    June 2, 2016
    Date of Event
    May 11, 2016
    Report Date
    May 25, 2016
    Manufacturer
    ANDOVER HEALTHCARE, INC.
    Product Code
    FQM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE WRAP HAS A NOXIOUS ODOR, PERHAPS PETROLEUM BASED? IT WAS SO STRONG, I HAD TO REMOVE THE WRAP AND THE CLOTHES OVER IT. MY EYES STUNG THERE WAS NO WARNING REGARDING USE OVER NON-INTACT SKIN OR ANY OTHER SITUATION. ANYTHING THAT SMELLS THAT BADLY, MUST HAVE TO BE DETOXIFIED BY THE LIVER OR KIDNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348567 POWER FLEX MED/SELF-ADHERING ELASTIC BANDAGE POWER FLEX MED/SELF-ADHERING ELASTIC BANDAGE FQM ANDOVER HEALTHCARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR