BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAL REEF GAIT BELT LONG

    MDR report key: 3932855 · Received March 11, 2014

    Report

    Report Number
    2020362-2014-00073
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Report Date
    February 5, 2014
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION AND HAS NOT BEEN RECEIVED. NOTE: THIS REPORT IS SUBMITTED BASED ON THE CUSTOMERS REPORTED ISSUE STATEMENT. RESULTS: FOR THE EVALUATION A RANDOMLY SELECTED SAMPLE WAS PULLED FROM FINISHED GOODS INVENTORY (MODEL# 6525/ LOT# 4057A12). THE SAMPLE WAS VISUALLY EVALUATED AND REVEALED NO PRODUCT ISSUE RELATED TO THE COMPLAINT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN THE GAIT BELTS ARE IN USE IN THE PHYSICAL THERAPY DEPARTMENT, THE TEETH TO THE GAIT BELTS ARE NOT LOCKING INTO THE MATERIAL CAUSING THE BELTS TO SLIP. THE DATE WHEN THE ISSUE WAS DISCOVERED IS UNKNOWN. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146336 CORAL REEF GAIT BELT LONG IKX J. T. POSEY CO. 6525L UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK