BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANE, CRUTCH AND WALKER TIPS AND PADS

    MDR report key: 2180567 · Received July 27, 2011

    Report

    Report Number
    1525712-2011-00386
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 13, 2011
    Report Date
    April 13, 2012
    Manufacturer
    DANYANG MAXTHAI MEDICAL EQUIPMENT
    Product Code
    INP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL PR (B)(4) ISSUED UF/IMPORTER REPORT #1525712-2011-00386. THE DEVICE, ROLLATOR, MODEL #65650, LOT #MX110415 WAS RETURNED FOR AN EVALUATION. THIS PRODUCT WAS 3 MONTHS OLD AT THE TIME OF THE INCIDENT. THE LEFT REAR CASTER SPOKES WERE BROKEN AT THE HUB. THIS TYPE OF DAMAGE IS NOT TYPICAL UNDER NORMAL USE CONDITIONS. THE EXACT FORM OF ABUSE IS UNKNOWN, BUT THIS DAMAGE CAN OCCUR FROM INCORRECT LOADING OR UNINTENDED USE SUCH AS THE CASTER STUCK AND THE CONSUMER ATTEMPTS TO FREE THE CASTER. THIS DAMAGE CAN ALSO OCCUR WHEN SELF PROPELLING OR NOT ENGAGING THE BRAKES CORRECTLY. FAILURE TO USE THE BRAKES WHILE SEATED OR ATTEMPTING TO SIT COULD CAUSE THE ROLLATOR TO SHIFT OR MOVE AWAY FROM THE USER AND RESULT IN USER INSTABILITY AND IMPROPER LOADING. BOTH THE INSTRUCTION SHEET AND A LABEL ON THE PRODUCT ALSO INDICATE NOT TO USE THIS DEVICE AS A WHEELCHAIR OR TRANSPORT DEVICE. THIS INCIDENT WAS MOST LIKELY DUE TO USER ERROR. COMPLAINT HISTORY WAS REVIEWED. THREE COMPLAINTS EXIST WITH BROKEN SPOKES. TWO HAVE NOT BEEN RETURNED AND THE MANUFACTURER AND AGE OF PRODUCTS ARE UNKNOWN. RMA (B)(4) HAS BEEN ISSUED FOR THE RETURN OF THIS ROLLATOR.

    Additional Manufacturer Narrative · 1

    RMA 859422910 HAS BEEN ISSUED FOR THE RETURN OF THIS ROLLATOR.

    Description of Event or Problem · 1

    THE CONSUMER STATES HE WAS USING THE ROLLATOR WHEN THE BACK LEFT WHEEL ALLEGEDLY BROKE, CAUSING THE CONSUMER TO FALL. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CONSUMER STATES HE WAS USING THE ROLLATOR WHEN THE BACK LEFT WHEEL ALLEGEDLY BROKE, CAUSING THE CONSUMER TO FALL. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANE, CRUTCH AND WALKER TIPS AND PADS 890.3790 INP DANYANG MAXTHAI MEDICAL EQUIPMENT 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 91 DA Other