BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 1842917 · Received September 20, 2010

    Report

    Report Number
    1525712-2010-00148
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    April 1, 2010
    Report Date
    September 20, 2010
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR RECEIVED SUMMONS ALLEGING THAT A USER HAD DISCOMFORT FROM ONE OF THEIR THIGHS RUBBING ON THEIR CHAIR RESULTING IN AN AMPUTATION OF THEIR LEG. NO DETAILS CONCERNING THE USER'S MEDICAL HISTORY WERE PROVIDED. INFO INDICATES THAT SOME FORM OF "RUBBING" OR SEATING IRRITATION WAS ENCOUNTERED BY THE USER WHEN THE DEVICE WAS INITIALLY DELIVERED TO THEM IN 2005. THE PT CONTINUED TO USE THE CHAIR AS RECEIVED FOR WELL OVER A YEAR. IT APPEARS THAT NEITHER THE FAMILY NOR THE USER DISCUSSED THE RUBBING WITH THE EQUIPMENT PROVIDER OR ANY HEALTH CARE PROFESSIONAL. MONITORING OF PT SKIN CONDITION INCLUDING THE CORRECTION OF ANY IRRITATION WOULD PREVENT SERIOUS INJURY AS DESCRIBED. THIS INCIDENT IS NOT THE RESULT OF PRODUCT DEFECT OR MALFUNCTION. SERIAL NUMBER OF PRODUCT HAS NOT BEEN PROVIDED. MDR FILED BASED ON ALLEGED INJURY.

    Description of Event or Problem · 1

    RECEIVED INFO FROM IVC LEGAL ALLEGING THE WHEELCHAIR BEGAN RUBBING THE LEFT THIGH OF THE CONSUMER SHORTLY AFTER HE RECEIVED THE CHAIR IN (B)(6) 2005. THE RUBBING ALLEGEDLY RESULTED IN A FRICTION WOUND IN LATE 2006, RESULTING IN THE AMPUTATION OF HIS LEFT LEG IN (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TDX3

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention