BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THUMB CMC ABDUCTION ORTOHSIS

    MDR report key: 8008919 · Received October 25, 2018

    Report

    Report Number
    MW5080820
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    October 5, 2018
    Report Date
    October 23, 2018
    Manufacturer
    NORTH COAST MEDICAL, INC.
    Product Code
    ILH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADVERSE REACTION TO THUMB CMC ABDUCTION ORTHOSIS PRESCRIBED FOR THUMB/WRIST SPRAIN (WAS ORIGINALLY AS BROKEN) MADE FROM NEOPRENE WITH ANTI-MICROBIAL TREATED TERRYCLOTH LINING. I DEVELOPED A BURN-LIKE REACTION ON WRIST THAT ITCHED, BLISTERED, PEELED AND ALSO DEVELOPED A RASH. THE BURN/PEELING WAS UNDER THE SPLINT ON THE WRIST AND THE RASH BEGAN AT THE BOTTOM OF MY THUMB AND EXTENDED ACROSS THE BACK OF MY HAND. ALMOST FOUR WEEKS LATER (REMOVING IT AFTER TWO WEEKS), I STILL HAVE THE RASH. MADE IN (B)(6), MFG BY NORTH COAST MEDICAL, INC. THANK YOU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844298 THUMB CMC ABDUCTION ORTOHSIS SPLINT, HAND, AND COMPONENTS ILH NORTH COAST MEDICAL, INC. NC79499-P

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other