BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 893181 · Received August 10, 2007

    Report

    Report Number
    2438477-2007-00003
    Event Type
    Injury
    Date Received
    August 10, 2007
    Date of Event
    July 10, 2007
    Report Date
    July 12, 2007
    Manufacturer
    MEDICAL DEPOT INC. (D/B/A DRIVE MEDICAL DESIGN & MFR)
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER REQUESTED THE WHEELCHAIR IMMEDIATELY BEFORE UTILIZING IT, WITH THE MAIN PURPOSE OF TRANSPORTING EQUIPMENT, INSTEAD OF A PERSON. THE ALLEGED WHEELCHAIR WAS NOT FOUND DEFECTIVE AT THE TIME OF INCIDENT BY EITHER THE USER OR THE HOSPITAL.

    Description of Event or Problem · 1

    USER WAS ACCOMPANYING HER HUSBAND IN THE HOSPITAL FOR HIS MRI TEST. THEY REQUIRED A WHEELCHAIR TO HELP TRANSPORT THE OXYGEN EQUIPMENT WHICH THE HUSBAND NEEDED. ALONG THE WAY, THE USER FOLDED THE WHEELCHAIR UP AND PASSED THROUGH A SINGLE DOORWAY, WHICH IS TOO NARROW FOR THE WHEELCHAIR TO PASS THROUGH WITHOUT FOLDING. AFTER PASSING THROUGH THE DOORWAY, THE USER TRIED TO OPEN THE WHEELCHAIR AGAIN, AND ALLEGES TO HAVE HAD ONE OF HER FINGERS (RIGHT FIFTH DIGIT) CAUGHT BETWEEN THE SEAT BASE AND SIDE OF THE WHEELCHAIR. THE FINGER WAS ALLEGEDLY FRACTURED. THE USER WAS ESCORTED TO THE ER IMMEDIATELY, WHERE ALLEGEDLY HER RIGHT FIFTH DIGIT NAIL WAS REMOVED, DIGIT WAS SET, LACERATION WAS SUTURED AND LATER REFERRED TO A HAND SURGEON. NO ADDITIONAL SURGICAL PROCEDURES WERE KNOWN TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL WHEELCHAIR IOR MEDICAL DEPOT INC. (D/B/A DRIVE MEDICAL DESIGN & MFR) SENTRA HD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention