BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY NON SKID SLIPPERS

    MDR report key: 1813219 · Received August 18, 2010

    Report

    Report Number
    2020362-2010-00166
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Report Date
    May 19, 2010
    Manufacturer
    DONGGUAN POSEY MEDICAL DEVICE LTD.
    Product Code
    IKX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - SOLE COMING OFF OF SLIPPER. THE PRODUCT HAS BEEN REQUESTED TO BE RETURNED BUT HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THAT THE MATERIAL AND SOLE IS SEPARATING ON THE NON SKID SLIPPERS WHILE IN USE ON A PATIENT IN THEIR HOME. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY NON SKID SLIPPERS IKX DONGGUAN POSEY MEDICAL DEVICE LTD. 6240S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI