BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACE (TM) HINHED KNEE BRACE

    MDR report key: 4186043 · Received October 2, 2014

    Report

    Report Number
    2110898-2014-00068
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    SINNING INDUSTRIAL CO. LTD.
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING NAME AND ADDRESS SHOULD BE CONSIDERED CONFIDENTIAL.

    Description of Event or Problem · 1

    CUSTOMER WORE FOR A COUPLE OF HOURS IN THE MORNING. THIS WAS THE FIRST TIME FOR THE CUSTOMER TO WEAR THIS BRACE. WHEN THE BRACE WAS REMOVED THERE WAS A SKIN REACTION IN THE AREA OF THE KNEE AND CALF. THE NEXT DAY THE CUSTOMER WENT TO A DOCTOR REGARDING THE SKIN REACTION. THE DOCTOR GAVE THE CUSTOMER MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614083 ACE (TM) HINHED KNEE BRACE 890.3475 LIMB ORTHOSIS IQI SINNING INDUSTRIAL CO. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK