BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1993519 · Received February 8, 2011

    Report

    Report Number
    1525712-2011-00039
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    July 19, 2010
    Report Date
    February 8, 2011
    Manufacturer
    INVACARE
    Product Code
    INN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED IN RESPONSE TO INVACARE'S COMMITMENT TO FDA (SEE (B)(4) DATED (B)(4) 2010) TO REVIEW ALL ADVERSE EVENT FILES PROCESSED IN THE LAST TWO YRS AND TO FILE MDRS AS NECESSARY, BASED ON INVACARE'S NEWLY REVISED COMPLAINT HANDLING PROCEDURE AND WORK INSTRUCTION. MFR RECEIVED LETTER FROM AN ATTORNEY ALLEGING A USER SUSTAINED AN UNCONFIRMED ALLEGED INJURY WHEN THEY WENT TO SIT IN A SHOWER CHAIR. NO DETAILS WERE PROVIDED ALONG WITH NO SERIAL NUMBER OR MODEL NUMBER. THE 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 MAY HAVE CAUSED OR CONTRIBUTED TO THIS ALLEGED INCIDENT. MFR HAS CONTACTED THE ATTORNEY FOR ADDITIONAL INFO REGARDING THE ALLEGED EVENT AND THE ATTORNEY HAS ADVISED THAT HE NO LONGER REPRESENTS THE CONSUMER AND HAS FORWARDED THE REQUESTED INFO TO NEW COUNSEL.

    Description of Event or Problem · 1

    RECEIVED INFO FROM IVC LEGAL ALLEGING THE SHOWER CHAIR COLLAPSED, CAUSING THE CONSUMER TO BE INJURED. NO DETAILS OF THE ALLEGED INJURY ARE KNOWN AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1