BEUDAMED
    FDA Adverse Event Other Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2100409 · Received May 16, 2011

    Report

    Report Number
    1525712-2011-00201
    Event Type
    Other
    Date Received
    May 16, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 13, 2011
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RIGHT SIDE OF THE WALKER ALLEGEDLY DID NOT LOCK. IT IS UNK IF CONSUMER FULLY OPENED THE WALKER WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED INCIDENT. MALFUNCTION HAS NOT BEEN ESTABLISHED. MFR IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION. MDR FILED BASED ON ALLEGED UNCONFIRMED MALFUNCTION.

    Description of Event or Problem · 1

    THE RIGHT SIDE OF THE WALKER ALLEGEDLY DID NOT LOCK AND SWUNG TO THE FRONT OF THE WALKER. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 6291-JR5F GT100825

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR