BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OR DIRECT SHOULDER BRACES

    MDR report key: 601571 · Received May 11, 2005

    Report

    Report Number
    1221538-2005-00004
    Event Type
    Injury
    Date Received
    May 11, 2005
    Report Date
    April 11, 2005
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT IS A PHYSICIAN WHO STATED THAT THEY ARE TESTIFYING IN A LAWSUIT PERTAINING TO AN ALLEGED BRACHIAL PLEXUS INJURY SUSTAINED BY A PT WHEN USING SHOULDER BRACES MANUFACTURED BY ALLEN MEDICAL SYSTEMS. THE ALLEGED INCIDENT OCCURRED IN A HOSPITAL APPROXIMATELY THREE YEARS PRIOR TO THE DATE OF THIS REPORT. THE COMPLAINANT WAS SEEKING INFORMATION ON THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OR DIRECT SHOULDER BRACES PATIENT POSITIONING DEVICE FWZ ALLEN MEDICAL SYSTEMS, INC. O-SBP-A1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention