BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTRUMENT, MANUAL, SURGICAL

    MDR report key: 644188 · Received October 28, 2005

    Report

    Report Number
    1825034-2005-00083
    Event Type
    Injury
    Date Received
    October 28, 2005
    Date of Event
    September 22, 2005
    Report Date
    October 3, 2005
    Manufacturer
    BIOMET, INC.
    Product Code
    EKD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING CARPAL TUNNEL RELEASE PROCEDURE IN 2005, PT COMPLAINED OF NUMBNESS. PT RETURNED TO SURGERY THREE DAYS LATER TO REPAIR MEDIAN NERVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTRUMENT, MANUAL, SURGICAL EKD BIOMET, INC. NA 603460

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention