BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2071827 · Received April 23, 2011

    Report

    Report Number
    1525712-2011-00169
    Event Type
    Injury
    Date Received
    April 23, 2011
    Date of Event
    March 7, 2011
    Report Date
    April 21, 2011
    Manufacturer
    UNK
    Product Code
    INM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON THE FIRST USE, THE USER FELT LIKE SOMETHING WAS WRONG WITH THE LEG OF THE DEVICE. WHEN SHE SAT ON THE CHAIR, THE LEGS ALLEGEDLY COLLAPSED AND ON ORIGINAL CONTACT NO INJURY WAS ALLEGED. MANUFACTURER SPOKE AGAIN WITH USER ON (B)(4) 2011 WHO NOW INDICATED THAT SINCE, THEY HAVE GONE TO THE DOCTOR'S OFFICE. PAST HISTORY WITH SIMILAR PRODUCTS INDICATES THAT USER INSTABILITY AND SUDDEN / IMPROPER DEVICE LOADING IS THE MOST LIKELY CAUSE OF THIS INCIDENT. PRODUCT HAS NOT BEEN RETURNED FOR EVAL AT THIS TIME, SO IT IS UNK IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR ABUSE OR LACK OF MAINTENANCE OR A SET UP ERROR MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. IF DEVICE IS RETURNED AND THE EVAL ESTABLISHES MALFUNCTION, THE DECISION NOT TO DO AN MDR WILL BE REVIEWED.

    Description of Event or Problem · 1

    THE CONSUMER BROUGHT THE SHOWER CHAIR HOME. UPON THE FIRST USE, THE FRONT LEG ALLEGEDLY SEEMED LIKE SOMETHING WAS WRONG. WHEN SHE SAT ON THE CHAIR, THE LEGS ALLEGEDLY COLLAPSED ON THE CHAIR. MANUFACTURER SPOKE WITH USER ON (B)(6) 2011 AND INDICATED THAT THEY HAVE GONE TO THE DOCTOR'S OFFICE.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention