BEUDAMED
    FDA Adverse Event Summary report: N

    WALGREEN'S BY ACE KNEE STABILIZER

    MDR report key: 4368230 · Received November 10, 2014

    Report

    Report Number
    2110898-2014-00076
    Date Received
    November 10, 2014
    Date of Event
    November 10, 2014
    Report Date
    November 10, 2014
    Manufacturer
    WINNING INDUSTRIAL CO. LTD.
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED TO THE MANUFACTURER. PRODUCT WAS NOT RETURNED FOR EVALUATION. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PER COMMUNICATIONS WITH THE CUSTOMER: CUSTOMER WORE THE BRACE FOR A FEW HOURS. WHEN HE TOOK THE BRACE OFF, HE HAD A RASH FROM WHERE THE TOP OF THE BRACE WAS TO THE BOTTOM OF BRACE. CUSTOMER WENT TO THE DOCTOR AND WAS GIVEN A WRAP TO WEAR AROUND THE AREA. SAYS HE WAS ALSO GIVEN STEROIDS TO HELP WITH THE SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724665 WALGREEN'S BY ACE KNEE STABILIZER 890.3475 LIMB ORTHOSIS IQI WINNING INDUSTRIAL CO. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK