BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACE

    MDR report key: 979978 · Received January 4, 2008

    Report

    Report Number
    MW5004964
    Event Type
    Other
    Date Received
    January 4, 2008
    Date of Event
    January 10, 2008
    Report Date
    January 10, 2008
    Manufacturer
    ACE
    Product Code
    IQI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I HAVE USED ACE BRAND WRIST BRACES WITH SPLINTS FOR MY CARPEL TUNNEL FOR SEVERAL YEARS. RECENTLY I BOUGHT A NEW PAIR. THE RIGHT ONE IS OK, BUT THE LEFT ONE CAUSED A SEVERE CHEMICAL OR RADIATION BURN ON MY HAND. I DID NOT WEAR THEM FOR A FEW WEEKS THEN UPON A SECOND USE THE SAME PROBLEM OCCURRED. THESE WRIST BRACES ARE MADE IN A FOREIGN COUNTRY AND I AM CONCERNED THAT THEY ARE CONTAMINATED. THE BURN THAT I RECEIVED ON MY HAND HAS BEEN VERY SEVERE AND EXTENDS DEEP INTO THE FLESH. IT HAS BEEN VERY SLOW TO HEAL AND CONTINUES TO BE A PROBLEM. I HAVE BEEN TREATED FOR THE BURN AT AN EMERGENCY CLINIC, BUT IT WILL NOT GO AWAY. I HAVE BEEN TREATED 3 TIMES FOR THIS CHEMICAL BURN. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: CARPEL TUNNEL SYNDROME. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES. EVENT REAPPEARED AFTER REINTRODUCTION? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACE WRIST BRACE WITH METAL SPLINT IQI ACE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other PREGNAZONE