BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACE WRIST WRAP

    MDR report key: 3833461 · Received May 21, 2014

    Report

    Report Number
    2110898-2014-00030
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 21, 2014
    Manufacturer
    WINNING INDUSTRIAL CO. LTD.
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING NAME AND ADDRESS SHOULD BE CONSIDERED CONFIDENTIAL. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER. PRODUCT WAS NOT RETURNED FOR EVAL. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    SHE HAD CARPEL TUNNEL SURGERY ON (B)(6) 2014 ON LEFT HAD AND IT WAS HEALING GOOD. SHE WOKE UP FROM HER SLEEP WITH HER WRIST HURTING ON (B)(6) REAL BAD, SO SHE WENT TO ER. THEY SAID SHE SPRAINED IT AND PUT IT IN A SPLINT. SHE LEFT THE ER AND WENT TO (B)(6). THAT'S WHEN SHE PURCHASED THE ACE BRACE. PUT IT ON IN THE CAR AND WITHIN MINUTES SHE FELT BURNING ON HER WRIST AND REMOVED THE BRACE RIGHT AWAY. NOTICE RASH COMING INSTANTLY, HER SKIN WAS GETTING RED, RAISED WITH LITTLE BLISTERS. GOT HOME AND CALLED THE DOCTOR (THAT DID THE SURGERY IN (B)(6)) AND SHE WENT INTO THE OFFICE THE NEXT MORNING AT 9 AM. HE THOUGHT SHE WAS HAVING AN ALLERGIC REACTION AND HAD GIVEN HER A RX FOR STEROID PACK AND WAS TOLD TO START IT RIGHT AWAY. IT WAS METHYIPREDNISOLO TABLET 4 ML. TOOK THE FIRST DOSE WHEN SHE PICKED IT UP. SHE THEN WENT TO HER PRIMARY DOCTOR APPOINTMENT A COUPLE HOURS LATER THAT SAME DAY. AT THAT APPOINTMENT HER ARM, EYES, LIPS AND TONGUE STARTED TO SWELLED UP AND SHE PASSED OUT. THEY CALLED 911 AND SHE WAS TAKEN TO THE HOSPITAL. SHE WAS AT THE HOSPITAL FOR A FEW HOURS AND WHEN SHE LEFT THEY GAVE HER HYDROXYZINE 50 MG 1X DAY FOR ITCH AND KETOCONAVOLE 2% CREAM APPLY 2X DAILY. SHE WAS ALSO TO CONTINUE WITH THE METHYIPREDNISOLO TABLET 4 MG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301753 ACE WRIST WRAP 890.3475 LIMB ORTHOSIS IQI WINNING INDUSTRIAL CO. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other