BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECONOMY TRANSFER BELT QR

    MDR report key: 3100006 · Received April 26, 2013

    Report

    Report Number
    2020362-2013-00191
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    March 19, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT DID NOT CONFIRM THE REPORTED ISSUE; THE MALE END IS NOT COMPLETELY BROKEN OFF. HOWEVER, ONE FINGER OF THE MALE END ON THE BUCKLE IS BROKEN OFF AND IS MISSING. THE MALE SIDE OF THE BUCKLE STILL CLICKS INTO THE FEMALE SIDE BUT IS NOT SECURE DUE TO THE CRACKED BODY UNDERNEATH THE REMAINING FINGER ON THE MALE SIDE. NOTE: INSTRUCTIONS FOR USE STATE: FASTEN ALL BUCKLES TO MINIMIZE DAMAGE DURING WASH AND DRY CYCLES. CLOSE HOOK AND LOOP FASTENERS BEFORE WASHING TO PREVENT LINT BUILD-UP. USE STIFF METAL BRUSH TO CLEAN "HOOK" MATERIAL AFTER WASHING. TEST HOOK AND LOOP ADHESION BEFORE USE, AND DISCARD BELT IF HOOK AND LOOP DOES NOT HOLD SECURELY. DURING THE WASHING, PROCESS, METAL BUCKLES COULD BEND AND QUICK-RELEASE BUCKLES COULD CRACK OR BREAK. DO NOT PUT BUCKLES THROUGH EXTRACTORS. ALWAYS ENSURE THAT ALL BUCKLES ARE IN GOOD WORKING ORDER AND ARE NOT CRACKED OR BROKEN BEFORE EACH USE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE MALE END OF THE BUCKLE BROKE OFF COMPLETELY. THE CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS FOUND. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181833 ECONOMY TRANSFER BELT QR IKX J. T. POSEY CO. 6537Q 040412

    Patients

    Seq Age Sex Outcome Treatment
    1 NA