BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHEELCHAIR, BARIATRIC, 26", REM F

    MDR report key: 1151437 · Received September 5, 2008

    Report

    Report Number
    1417592-2008-00029
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 2, 2008
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IOR
    Removal / Correction Number
    1417592-3/19/08
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT INVOLVED A STAFF MEMBER WHO WENT TO OPEN THE CHAIR AND WHEN SHE DID, SHE PLACED HER FINGERS AROUND THE SEAT TUBES TO PUSH DOWN THE SEAT. WHEN IT SNAPPED OPEN, IT CAUGHT ONE OF HER FINGERS. IT REQUIRED SURGICAL INTERVENTION TO REPAIR IT. THE ACCOUNT CONFIRMED THAT WARNING STICKERS WERE IN PLACE INDICATING THAT THE END USER SHOULD AVOID PLACING FINGERS AND HANDS AROUND THE SET TUBES. THE UPHOLSTERY ON THE CHAIR HAD NOT BEEN UPGRADED WHICH WAS PART OF THE FIELD CORRECTIVE ACTION. THE UPGRADE HAS SINCE BEEN ADDRESSED. THE CORRECTIVE ACTION REPORTING NUMBER IS 1417592-3/19/2008-0001-C. NO FURTHER CORRECTIVE ACTION IS INDICATED.

    Description of Event or Problem · 1

    A STAFF MEMBER WAS OPENING THE CHAIR, AND THE TIP OF HER FINGER WAS CAUGHT. IT REQUIRED SURGICAL INTERVENTION TO REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHEELCHAIR, BARIATRIC, 26", REM F WHEELCHAIR IOR MEDLINE INDUSTRIES, INC. MDS809750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other