BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEN MEDICAL SYSTEM

    MDR report key: 755512 · Received August 21, 2006

    Report

    Report Number
    MW1040137
    Event Type
    Injury
    Date Received
    August 21, 2006
    Date of Event
    May 2, 2006
    Report Date
    August 21, 2006
    Manufacturer
    ALLEN MEDICAL SYSTEM
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEUROSURGEON REPORTED TO THE ALLEN BED VENDOR THAT HE HAD 4 CASES WITH COMPLICATIONS OF BRACHIAL PLEXUS INJURIES POST OPERATIVE. THIS PATIENT HAD UNEQUAL GRIPS AND DIFFICULTY MOVING POST OP FOLLOWING THE USE OF THE ALLEN SPINAL SYSTEM BED AFTER A POSTERIOR LUMBAR INTRAVERTBRAL DECOMPRESSION. CASE WAS 5-7 HOUR DURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEM ALLEN SPINAL SYSTEM FWZ ALLEN MEDICAL SYSTEM A70000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention