BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACE KNEE BRACE WITH DUAL SIDE STABILIZER

    MDR report key: 3836102 · Received May 14, 2014

    Report

    Report Number
    2110898-2014-00029
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    WINNING INDUSTRIAL CO, LTD
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFG NAME AND ADDRESS SHOULD BE CONSIDERED CONFIDENTIAL. METHOD - PRODUCT WAS NOT RETURNED TO THE MFR. RESULT - PRODUCT WAS NOT RETURNED FOR EVAL. CONCLUSION - NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT SHE HAD AN ALLERGIC REACTION TO OUR PRODUCT (200290). ON (B)(6) 2014 AT APPROX 11:00 AM CUSTOMER PUT THE PRODUCT ON RIGHT KNEE AND HAD THE BRACE ON FOR APPROX 2 HOURS REMOVING APPROX 1:00 PM. ONE THE BRACE WAS REMOVED SHE NOTICED THAT HER KNEE WAS RED, AN HOUR LATER THERE WAS SWELLING, HIVES, AND ITCHING AROUND WHERE THE BRACE WAS ON THE KNEE. CUSTOMER TOOK BENADRYL FRIDAY NIGHT, ALL DAY SATURDAY. ON SUNDAY MORNING AT APPROX () SHE WENT TO EMERGENCY ROOM. CUSTOMER WAS GIVEN (3) RX'S PREDNISONE 50MG (1 TAB BY MOUTH), FAMOTIDINE 20MG (1 TAB 2X DAY) AND BENADRYL 50 MG EVERY 4-6 HOURS AS NEEDED FOR ITCHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287865 ACE KNEE BRACE WITH DUAL SIDE STABILIZER LIMB ORTHOSIS IQI WINNING INDUSTRIAL CO, LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK