BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEN MEDICAL SYSTEMS

    MDR report key: 997246 · Received February 13, 2008

    Report

    Report Number
    1221538-2008-00001
    Event Type
    Injury
    Date Received
    February 13, 2008
    Date of Event
    May 9, 2003
    Report Date
    February 13, 2008
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO RETURN OF THE DEVICE, NOR WAS THE INCIDENT WHICH TOOK PLACE ALMOST FIVE YEARS AGO, EVER REPORTED TO ALLEN MEDICAL BY THE USERS OF THE DEVICE. BASED ON THE DESCRIPTION OF THE FAILURE AS DESCRIBED IN THE LEGAL PAPERS, IT IS ALLEN MEDICAL'S OPINION THAT THE MOST LIKELY ROOT CAUSE FOR THIS INCIDENT IS USER ERROR DURING INSTALLATION OF THE PRODUCT ON THE SURGICAL TABLE.

    Description of Event or Problem · 1

    ON JAN 15, 2008, AN ALLEN SALES REP WAS SERVED WITH LEGAL PAPERS FOR A LAWSUIT RESULTING FROM A PREVIOUSLY UNREPORTED INJURY SUSTAINED DURING A 2003 PROCEDURE. ACCORDING TO THE COMPLAINT, THE PATIENT ARRIVED AT ALL SAINTS SURGERY CENTER - A MEDICAL FACILITY IN 2003, FOR A RIGHT SHOULDER ARTHROSCOPY PROCEDURE. THIS SURGERY WAS SCHEDULED TO INCLUDE A SYNOVIAL DEBRIDEMENT AND SUBACROMIAL DECOMPRESSION. ACCORDING TO THE LEGAL PAPERS: "DURING THE SURGERY IN 2003, THE DEFENDANT, AND ITS STAFF DID NOT ADEQUATELY SECURE THE OPERATING TABLE THEREBY ALLOWING THE TABLE TO FALL ABRUPTLY TO THE GROUND WITH THE PLAINTIFF ON THE OPERATING TABLE, CAUSING THE PLAINTIFF TO HANG BY HIS LEGS FROM THE TABLE." THE LEGAL PAPERS ALSO STATE: "DURING THE SURGERY PRIOR TO EVENT DATE, AT FACILITY, THE 'BEACH CHAIR' MANUFACTURED BY DEFENDANT ALLEN MEDICAL SYSTEMS, INC., STRUCTURALLY FAILED TO ADEQUATELY SUPPORT AND POSITION THE PLAINTIFF ON IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEMS BEACH CHAIR FWZ ALLEN MEDICAL SYSTEMS A-90000-A3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Disability