BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY SCALPEL

    MDR report key: 2641411 · Received June 29, 2012

    Report

    Report Number
    1721504-2012-00068
    Event Type
    Malfunction
    Date Received
    June 29, 2012
    Date of Event
    June 14, 2012
    Report Date
    June 14, 2012
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    GDX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVAL. THE USER DID NOT INDICATE IF THIS WAS THE INITIAL USE OF THE DEVICE. THE EVAL IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE DEVICE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE SCALPEL BLADE WILL NOT RECOIL INTO THE HANDLE BECAUSE THE BLADE HAD SHOT OUT OF THE HANDLE. NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETY SCALPEL MANUAL SURGICAL INSTRUMENTS FOR GENERAL GDX MERIT MEDICAL SYSTEMS, INC. D125509

    Patients

    Seq Age Sex Outcome Treatment
    1