BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2142593 · Received June 21, 2011

    Report

    Report Number
    1525712-2011-00272
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    March 22, 2011
    Report Date
    June 20, 2011
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    INM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2011 - (B)(6) - NO ALLEGED SERIOUS INJURY. ALLEGED MALFUNCTION. ALLEGEDLY, THE CONSUMER'S ROLLATOR FRONT WHEEL BROKE CAUSING THE CONSUMER TO FALL. THE CONSUMER IS A (B)(6) YEAR OLD FEMALE WHO WEIGHS (B)(6) LBS AND IS (B)(6) INCHES TALL. THE CONSUMER'S MEDICAL CONDITION AND STABILITY ARE UNKNOWN. THE CONSUMER'S MEDICATION REGIMEN IS UNK. ANY ADDITIONAL LOADING TO THE DEVICE IS UNK. THE ENVIRONMENTAL CONDITIONS FOR THE FLOORING, CARPETING, TILING OR TERRAIN ARE UNK. PRODUCT USAGE TECHNIQUE IS UNK. NOTE: THIS PRODUCT IS NOT MEANT TO MIMIC A WHEELCHAIR IN ITS USE. IT IS FOR WALKING SUPPORT AND STATIONARY RESTING ONLY; BEING PUSHED OR SELF PROPELLING WHILE SEATED IS NOT ITS INTENDED USE.

    Description of Event or Problem · 1

    THE CONSUMER WAS SITTING ON THE SEAT WHEN THE FRONT CASTER ALLEGEDLY BROKE, CAUSING HER TO FALL. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE INM GENTEEL HOMECARE PRODUCTS 65100 GT091021

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR