BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEN MEDICAL SYSTEMS

    MDR report key: 1079529 · Received July 21, 2008

    Report

    Report Number
    1221538-2008-00005
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    May 18, 2006
    Report Date
    June 23, 2008
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS AT WHITE COUNTY MEDICAL FOR A MAY 2006 PROCEDURE CONDUCTED BY NEUROSURGEON DUE TO POSITIONING TECHNIQUE DURING THE PROCEDURE, THE MALE PT REPORTEDLY SUFFERED A PERMANENT BRACHIAL PLEXUS NERVE INJURY. THERE IS HISTORICAL PRECEDENCE AT THIS FACILITY: IN 2006, DR REPORTED A SIMILAR NERVE INJURY SUSTAINED BY ANOTHER OF HIS PTS. (REFERENCE MEDWATCH 1221538-2006-00006). AT THAT TIME, DR SAID HE HAD EXPERIENCED DIFFICULTIES WITH POSITIONING CASES, BUT DID NOT RELAY THAT THERE WERE ANY SERIOUS INJURIES OR THAT PERMANENT DISABILITIES HAD BEEN SUSTAINED. THE LOCAL ALLEN REP HAS LEARNED THAT DR IS THE ONLY SURGEON ON THE STAFF WHO HAD USED THE FLEX FRAME AND HE IS NO LONGER EMPLOYED AT THE HOSP. THERE IS NO DEVICE FAILURE TO EVALUATE OR SAFETY ISSUE FOR INVESTIGATION. THERE HAS BEEN NO CLAIM FROM THE USER FACILITY THAT THE FLEX FRAME TABLE EXTENSION FAILED OR MALFUNCTIONED IN ANY WAY.

    Description of Event or Problem · 1

    ON 06/23/2008, AN ALLEN MEDICAL REP WAS CONTACTED BY THE WHITE COUNTY MEDICAL CENTER, REQUESTING A COPY OF THE ALLEN FLEX FRAME OPEN TABLE EXTENSION'S INSTRUCTION FOR USE AS THEY PREPARED FOR A MALPRACTICE LAWSUIT FILED BY A FORMER PT. THE PREVIOUSLY UNREPORTED PT INJURY CLAIM REPORTEDLY OCCURRED AT THE USER FACILITY IN 2006. THE PT'S ATTORNEY'S CLAIM THAT THEIR CLIENT SUFFERED NERVE DAMAGE (A BRACHIAL PLEXUS INJURY) CAUSED BY THE SURGEON/FACILITY'S POOR POSITIONING OF THEIR CLIENT DURING THE PROCEDURE.

    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 UNK Disability