BEUDAMED
    FDA Adverse Event Other Summary report: N

    DAILY ACTIVITY ASSIST DEVICES - UTENSIL FOR DRESSING, GROOMING, RECREAT

    MDR report key: 2120509 · Received June 3, 2011

    Report

    Report Number
    1525712-2011-00235
    Event Type
    Other
    Date Received
    June 3, 2011
    Date of Event
    April 27, 2011
    Report Date
    June 2, 2011
    Manufacturer
    UNK
    Product Code
    INM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER ALLEGES THE LEGS BENT ON THE SHOWER CHAIR AND THAT SHE FELL BACK. CONSUMER WENT TO AN URGENT CARE FOR TREATMENT AND WAS RELEASED. CONSUMER STATED SHE IS FOLLOWING UP WITH A DOCTOR'S VISIT. PRODUCT WAS APPROXIMATELY ONE YEAR OLD AT THE TIME OF THE INCIDENT WITH NO PREVIOUS COMPLAINTS. PRODUCT HAS NOT BEEN RETURNED FOR AN EVALUATION SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE, ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MDR FILED BASED ON ALLEGED UNCONFIRMED MALFUNCTION.

    Description of Event or Problem · 1

    THE CONSUMER STATES SHE WAS DIZZY DUE TO THE REAR LEGS ALLEGEDLY BENDING AND THEN GAVE OUT, CAUSING HER TO FALL BACKWARDS AND HIT HER HEAD, NECK AND SHOULDERS IN THE TUB. THE CONSUMER WENT TO URGENT CARE AND WAS RELEASED AND TOLD TO FOLLOW UP WITH HER DOCTOR. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES - UTENSIL FOR DRESSING, GROOMING, RECREAT 890.5050 INM UNK 96-2 PW100101

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR