BEUDAMED
    FDA Adverse Event Other Summary report: N

    WHEELCHAIR, BARIATRIC, 24", R

    MDR report key: 1032477 · Received April 17, 2008

    Report

    Report Number
    1417592-2008-00009
    Event Type
    Other
    Date Received
    April 17, 2008
    Report Date
    April 16, 2008
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IOR
    Removal / Correction Number
    1417592-3/19/08-0001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE STAFF MEMBER WAS ATTEMPTING TO OPEN THE WHEELCHAIR. SHE PUSHED ON THE SEAT TUBES AND WHEN IT FULLY OPENED, HER FINGER WAS CAUGHT. A FRACTURE OF HER FINGER RESULTED. THE FINGER WAS SPLINTED. A FIELD CORRECTIVE WAS INITIATED. THE CORRECTIVE ACTION REPORTING NUMBER IS 1417592-2/19/08-0001-C. AS PART OF THE FIELD RE-WORK, THE FACILITY RECEIVED NEW SEAT BACKS WHICH ARE WIDER AND SLOW THE OPENING MOMENTUM OF THE DEVICE. LARGER WARNING LABELS AND STAFF TRAINING MATERIALS WERE ALSO PROVIDED.

    Description of Event or Problem · 1

    STAFF MEMBER WAS OPENING WHEELCHAIR AND PLACED FINGERS AROUND SEAT TUBE WHILE PRESSING DOWN ON THE SEAT. HER FINGER WAS CAUGHT IN THE DEVICE. A FRACTURE RESULTED. SHE WAS SEEN BY A HAND SURGEON. THE FINGER WAS SPLINTED. NO SURGICAL INTERVENTION WAS INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHEELCHAIR, BARIATRIC, 24", R NONE IOR MEDLINE INDUSTRIES, INC. MDS809600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention