BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY NON-SKID SLIPPERS

    MDR report key: 1811109 · Received August 13, 2010

    Report

    Report Number
    2020362-2010-00167
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Report Date
    July 14, 2010
    Manufacturer
    POSEY MEDICAL DEVICE LTD.
    Product Code
    IKX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SLIPPER SOLE SEPARATED FROM WHERE RUBBER MEETS. EVAL RESULTS: EVAL FOR THE RETURNED SIX PAIRS OF SLIPPERS FOUND THAT THREE PAIRS OF SLIPPERS WERE USED AND THE SOLES ARE COMING OFF. THREE PAIRS OF SLIPPERS WERE RETURNED IN THEIR ORIGINAL SEALED PACKAGING WITH NO PRODUCT PROBLEM FOUND. (B)(4).

    Description of Event or Problem · 1

    RPTR STATED THE PT WAS AT HOME WEARING THE PRODUCT SLIPPERS AND WHILE BEING AMBULATED THE PT FELL. THERE IS VISIBLE DAMAGE TO THE SLIPPERS WHERE THE SOLE AND RUBBER MEETS, WHICH IS NOT SEPARATED. THERE WAS NO PT SERIOUS INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI