BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEN MEDICAL SYSTEMS SHOULDER CHAIR

    MDR report key: 754686 · Received August 25, 2006

    Report

    Report Number
    1221538-2006-00006
    Event Type
    Injury
    Date Received
    August 25, 2006
    Date of Event
    June 2, 2006
    Report Date
    August 25, 2006
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT LAST CONTACT WITH THE FACILITY, THE TABLE EXTENSION HAD BEEN QUARANTINED. IT HAS NOT BEEN RETURNED OR OTHERWISE MADE AVAILABLE FOR EVALUATION. ACCORDING TO A HOSPITAL SPOKESMAN - THE DAY FOLLOWING SURGERY, THE PATIENT TOLD ATTENDING NURSES THAT SHE WAS EXPERIENCING SYMPTOMS OF NERVE DAMAGE, INCLUDING DECREASED MOTION IN THE ARMS (FLACID) AND THE INABILITY TO RAISE HER ARMS ABOVE HER HEAD WITH GENERAL WEAKNESS ON THE RIGHT SIDE. THER IS NO INDICATION FROM THE FACILITY OR THE SURGEON THAT THE FLEX FRAME TABLE EVER FAILED OR MALFUNCTIONED.

    Description of Event or Problem · 1

    A FEMALE PATIENT SUFFERED A NERVE INJURY BELIEVED TO BE BRACHIAL PLEXUS FOLLOWING A SPINAL SURGERY AT FACILITY, THAT REQUIRED PROLONGED PRONE POSITIONING. THE PROCEDURE TOOK PLACE IN 2006, BUT THE INCIDENT WAS NOT MADE KNOWN UNTIL LATER. DR., THE CASE NEUROSURGEON, TOLD AN ALLEN MEDICAL REPRESENTATIVE ON 7/26/06, THAT THE PATIENT SUFFERED A BRACHIAL PLEXUS INJURY FOLLOWING A SPINAL SURGERY. IT IS BELIEVED THAT PATIENT POSITIONING WAS THE CAUSE. THE SPINAL SYSTEM WAS NOT REPORTED TO HAVE MALFUNCTIONED. ALL SUBSEQUENT REQUESTS FOR PATIENT INJURY INFORMATION INCLUDING RECOVERY STATUS HAVE GARNERED NO RESPONSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Disability