BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2071828 · Received April 23, 2011

    Report

    Report Number
    1525712-2011-00168
    Event Type
    Injury
    Date Received
    April 23, 2011
    Date of Event
    January 3, 2011
    Report Date
    April 21, 2011
    Manufacturer
    INVACARE
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR RECEIVED INFO FROM AN INSURANCE CARRIER THAT A CONSUMER CUT HER LEG REQUIRING STITCHES WHILE TRANSFERRING OUT OF A CHAIR IN AN AUTO PARTS STORE. NO SERIAL NUMBER HAS BEEN PROVIDED. DEVICE SERVICE AND MAINTENANCE HISTORY IS UNK. USER INDICATED THEY SMASHED THEIR LEG WHILE TRANSFERRING OUT OF THE CHAIR. UNCLEAR IF PROPER TRANSFER METHODS WERE FOLLOWED. MDR FILED BASED ON ALLEGED INJURY. 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 HIS INCIDENT. NATURE OF COMPLAINT SUGGESTS A POTENTIAL LOSS OF BALANCE AND/OR TRANSFER ERROR. MALFUNCTION NOT CONFIRMED. MDR FILED BASED ON ALLEGED SERIOUS INJURY.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGEDLY CUT HER LEG ON THE FOOTREST OF THE WHEELCHAIR, RESULTING IN 9 STITCHES TO HER LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE T4

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention