BEUDAMED
    FDA Adverse Event Other Summary report: N

    WHEELCHAIR, BARIATRIC, 26'

    MDR report key: 1023722 · Received March 28, 2008

    Report

    Report Number
    1417592-2008-00006
    Event Type
    Other
    Date Received
    March 28, 2008
    Date of Event
    October 3, 2007
    Report Date
    March 21, 2008
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IOR
    Removal / Correction Number
    1417592-3/19/08
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT INVOLVED A STAFF MEMBER WHO WAS OPENING THE WHEELCHAIR AND FRACTURED HER FINGER WHEN IT WAS CAUGHT. NO SURGICAL INTERVENTION WAS INDICATED. THE FACILITY REPORTED NO OTHER DETAILS REGARDING THE INJURY OR TREATMENT, BUT STATED THERE WERE NO COMPLICATIONS. A FIELD CORRECTION HAS BEEN INITIATED. AS PART OF THE FIELD RE-WORK, NEW SEAT BACKS ARE BEING PROVIDED TO THE FACILITY WHICH ARE WIDER AND WILL SLOW THE OPENING MOMENTUM OF THE DEVICE. LARGER WARNING LABELS ARE ALSO BEING PROVIDED AS WELL AS STAFF TRAINING MATERIALS.

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN 2007, BUT WE HAVE NOW JUST BEEN NOTIFIED. A STAFF MEMBER APPARENTLY HAD BEEN OPENING UP THE WHEELCHAIR. HER FINGERS WERE PLACED NEAR THE SEAT TUBES AND WHEN IT FULLY OPENED, HER FINGER WAS PINCHED. IT RESULTED IN A FRACTURE. NO SURGICAL INTERVENTION WAS INDICATED. SHE RETURNED TO WORK THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHEELCHAIR, BARIATRIC, 26' WHEELCHAIR IOR MEDLINE INDUSTRIES, INC. MDS809700 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention