BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAL REEF COTTON GAIT BELT STANDARD

    MDR report key: 3131694 · Received May 6, 2013

    Report

    Report Number
    2020362-2013-00208
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Report Date
    April 8, 2013
    Manufacturer
    J. T. POSEY CO.
    Product Code
    IKX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN REQUESTED TO BE RETURNED BUT HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE BUCKLE IS PLACED BACKWARDS ON THE GAIT BELT. CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS FOUND. THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197897 CORAL REEF COTTON GAIT BELT STANDARD IKX J. T. POSEY CO. 6525 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK