BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE SHOWER/BATH SUPPORT PRODUCTS

    MDR report key: 1060876 · Received June 13, 2008

    Report

    Report Number
    1525712-2008-00046
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    November 2, 2007
    Report Date
    June 6, 2008
    Manufacturer
    INVACARE CORP - MFG FACILITY
    Product Code
    INM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    MFR RECEIVED INFO INDICATING CONSUMER FELL WHILE USING THE SHOWER CHAIR, CUTTING HIS HEAD AND REQUIRING 7 STAPLES. 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, LACK OF MAINTENANCE OR A USER ERROR MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MDR FILED BASED ON INJURY.

    Description of Event or Problem · 1

    THE CONSUMER'S DAUGHTER ALLEGES THE CONSUMER FELL WHILE USING THE SHOWER CHAIR, CUTTING HIS HEAD AND REQUIRING 7 STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE SHOWER/BATH SUPPORT PRODUCTS 890.3100 INM INVACARE CORP - MFG FACILITY 9781 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention