BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEN MEDICAL SYSTEMS

    MDR report key: 785337 · Received November 17, 2006

    Report

    Report Number
    1221538-2006-00007
    Event Type
    Injury
    Date Received
    November 17, 2006
    Date of Event
    October 17, 2006
    Report Date
    November 17, 2006
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THREE DAYS AFTER THE PATIENT SURGERY, A TRAINED ALLEN REPRESENTATIVE FAMILIAR WITH THE USE OF THIS DEVICE EVALUATED THE UNIT AT THE FACILITY AND FOUND IT TO HAVE NO ISSUES. THE ALLEN REP DETERMINED THE FACILITY STAFF MAY HAVE POSITIONED THE CHEST PADS TOO SUPERIORLY TO SUPPORT THE PATIENT IN THIS CASE. THE ALLEN REP CONFIRMED THAT ONE OF THE CHEST PADS SHIFTED OFF OF ITS BASE UNDER THE PATIENT'S WEIGHT AND THE PATIENT WAS RESTING PARTIALLY ON THE PLASTIC BASE DURING THIS LENGTHY OPERATION. THE STAFF WAS GIVEN A NEW INSERVICE TRAINING FOR THE PRODUCT PRIOR TO THE INITIATION OF ANY NEW SURGERIES. THERE IS NO INDICATION FROM THE FACILITY THAT THE FLEX FRAME TABLE EVER FAILED OR MALFUNCTIONED IN ANY WAY.

    Description of Event or Problem · 1

    A FEMALE PATIENT SUSTAINED A BRACHIAL PLEXUS INJURY FOLLOWING A 13-HOUR SPINAL SURGERY AT HOSPITAL IN WHICH THE ALLEN FLEX FRAME TABLE EXTENSION WAS BEING USED. THE PROCEDURE TOOK PLACE IN 2006 AND WAS REPORTED TO AN ALLEN MEDICAL REPRESENTATIVE ON SITE 3 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEMS ALLEN FLEX FRAME TABLE EXTENSION FWZ ALLEN MEDICAL SYSTEMS A-70100-A1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability