BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOUTHMEDIC POLYMER COATED SURGICAL BLADE

    MDR report key: 2629043 · Received December 23, 2011

    Report

    Report Number
    8022032-2011-00001
    Event Type
    Malfunction
    Date Received
    December 23, 2011
    Date of Event
    November 22, 2011
    Report Date
    December 9, 2011
    Manufacturer
    SOUTHMEDIC, INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE MALFUNCTION DURING ARTHROSCOPIC KNEE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOUTHMEDIC POLYMER COATED SURGICAL BLADE GES #11 SURGICAL BLADE GES SOUTHMEDIC, INC. 73-0411 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other