BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A-DEC 1601 DOCTOR'S STOOL

    MDR report key: 2176689 · Received November 12, 2008

    Report

    Report Number
    3015729-2008-00001
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 10, 2008
    Report Date
    November 12, 2008
    Manufacturer
    A-DEC, INC.
    Product Code
    KLC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STOOL BASE THAT FRACTURED ON ONE OF FIVE ARMS IS MANUFACTURED BY: LEGGETT & PLATT, (B)(4). THE STOOL BASE FRACTURE WAS A MANUFACTURER'S DEFECT TRACEABLE TO A MOLD EJECTION AND/OR COLD FLOW ISSUE IN THE MOLD CAVITY AROUND ARM WEBBING. THESE BASES ARE INSPECTED, CLEANED, POWDER-COATED AND ASSEMBLED INTO VARIOUS STOOL MODELS BY A-DEC, INC.

    Description of Event or Problem · 1

    INITIAL REPORT DID NOT INDICATE TRUE LEVEL OF INJURY, SUBSEQUENT REPORT (B)(6) 2008 INDICATED. DR. (B)(6) WAS AWAITING MRI AND POSSIBLE ROTATOR CUFF SURGERY AS A RESULT OF EQUIPMENT DEFECT AND SUBSEQUENT FAILURE. EVENT: A DOCTOR'S STOOL BASE FAILED ON ONE OF FIVE WEBS AND CAUSED DR. ANTHONY TO FALL AND STRIKE HIS SHOULDER ON FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 A-DEC 1601 DOCTOR'S STOOL STOOL KLC A-DEC, INC. 1601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention