BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE PATIENT USE GAIT BELT

    MDR report key: 5030426 · Received August 25, 2015

    Report

    Report Number
    2020362-2015-00057
    Event Type
    Malfunction
    Date Received
    August 25, 2015
    Report Date
    September 11, 2015
    Manufacturer
    J.T. POSEY COMPANY
    Product Code
    IKX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION AND HAS NOT BEEN RECEIVED. NOTE: THIS REPORT IS BASED SOLELY ON THE CUSTOMER REPORTED ISSUE. THE INSTRUCTIONS FOR USE STATE: ALWAYS 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. NEVER USE SOILED OR DAMAGED PRODUCTS. (B)(4).

    Additional Manufacturer Narrative · 1

    WITHOUT THE RETURN OF THE PRODUCT AND/OR IMAGES PROVIDED, THE COMPLAINT COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER COULD NOT BE OBTAINED. A HISTORICAL REVIEW OF THE DATABASE FOUND THE SIMILAR COMPLAINTS OF BROKEN QUICK RELEASE BUCKLES WERE RELATED TO EITHER WEAR AND TEAR OR POSSIBLY AN ISSUE WITH THE MOLDING (THE LATTER HAS NOT BEEN PROVEN). ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY AT THIS TIME. MANUFACTURER REFERENCE FILE # (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED WHILE AMBULATING WITH HER HUSBAND THE BUCKLE BROKE. CUSTOMER DID NOT PROVIDE THE DATE OF THE EVENT AND NO INJURIES WERE REPORTED.

    Description of Event or Problem · 1

    A SUPPLEMENTAL MEDWATCH IS REQUIRED FOR ADDITIONAL PRODUCT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561103 SINGLE PATIENT USE GAIT BELT AID, TRANSFER IKX J.T. POSEY COMPANY 6556Q NI

    Patients

    Seq Age Sex Outcome Treatment
    1