BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2142599 · Received June 21, 2011

    Report

    Report Number
    1525712-2011-00281
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Report Date
    June 20, 2011
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALLEGED SERIOUS INJURY. ALLEGED MALFUNCTION. ALLEGEDLY, THE CONSUMER PARKED THE ROLLATOR AND LOWERED HIMSELF ONTO THE SEAT. ONCE HE PUT HIS FULL BODY WEIGHT ONTO THE SEAT OF THE ROLLATOR, HE HEARD A POP AND THE WELD BROKE. THE CONSUMERS AGE, WEIGHT AND HEIGHT ARE UNKNOWN. THE CONSUMERS' MEDICAL CONDITION AND STABILITY ARE UNKNOWN. THE CONSUMERS' MEDICATION REGIMEN IS UNKNOWN. ANY ADDITIONAL LOADING TO THE DEVICE IS UNKNOWN. PRODUCT USAGE TECHNIQUE IS UNKNOWN. NOTE: THIS PRODUCT IS NOT MEANT TO MIMIC A WHEELCHAIR IN ITS USE. IT IS FOR WALKING SUPPORT AND STATIONARY RESTING; BEING PUSHED OR SELF PROPELLING WHILE SEATED IS NOT ITS INTENDED USE. CORRECTION: INITIALLY THE MANUFACTURER WAS IDENTIFIED AS (B)(4) - THE MANUFACTURER IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    NO ALLEGED SERIOUS INJURY. ALLEGED MALFUNCTION. ALLEGEDLY, THE CONSUMER PARKED THE ROLLATOR AND LOWERED HIMSELF ONTO THE SEAT. ONCE HE PUT HIS FULL BODY WEIGHT ONTO THE SEAT OF THE ROLLATOR, HE HEARD A POP AND THE WELD BROKE. THE CONSUMER'S AGE, WEIGHT AND HEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION AND STABILITY ARE UNKNOWN. THE CONSUMER'S MEDICATION REGIMEN IS UNKNOWN. ANY ADDITIONAL LOADING TO THE DEVICE IS UNKNOWN. PRODUCT USAGE TECHNIQUE IS UNKNOWN. NOTE: THIS PRODUCT IS NOT MEANT TO MIMIC A WHEELCHAIR IN ITS USE. IT IS FOR WALKING SUPPORT AND STATIONARY RESTING; BEING PUSHED OR SELF PROPELLING WHILE SEATED IS NOT ITS INTENDED USE.

    Description of Event or Problem · 1

    THE CONSUMER STATES HE PARKED THE ROLLATOR AND LOWERED HIMSELF ONTO THE SEAT. ONCE HE PUT HIS WEIGHT ON THE SEAT OF THE ROLLATOR, HE ALLEGEDLY HEARD A POP AND A WELD BROKE. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CONSUMER STATES HE PARKED THE ROLLATOR AND LOWERED HIMSELF ONTO THE SEAT. ONCE HE PUT HIS WEIGHT ON THE SEAT OF THE ROLLATOR, HE ALLEGEDLY HEARD A POP AND A WELD BROKE. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 65650R NA

    Patients

    Seq Age Sex Outcome Treatment
    1