BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY ERGONOMIC WALKING BET

    MDR report key: 3062603 · Received March 18, 2013

    Report

    Report Number
    2020362-2013-00124
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Report Date
    February 20, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE REPORTED ISSUE THAT THERE IS SEAM DAMAGE WAS CONFIRMED. EVALUATION REVEALED THAT THE PRODUCT HANDLE MATERIAL IS TORN ABOVE THE STITCHING AREA. NOTE: POSEY INSTRUCTIONS FOR USE WARNING STATES: INSPECT BEFORE EACH USE: CHECK FOR BROKEN STITCHES OR PARTS; TORN, CUT OR FRAYED MATERIAL; OR BUCKLES THAT ARE CRACKED OR BROKEN AND DO NOT HOLD SECURELY. DO NOT USE SOILED OR DAMAGED PRODUCTS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SEAM WHERE THE HANDLE IS SEWN ON TO THE BELT HAS COME APART. CUSTOMER DID NOT PROVIDE THE DATE WHEN THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT CONTACT OR INCIDENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112671 POSEY ERGONOMIC WALKING BET IKX J. T. POSEY CO. 6534L 070711

    Patients

    Seq Age Sex Outcome Treatment
    1 NA