BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY MITEK INC.

    MDR report key: 1917291 · Received December 1, 2010

    Report

    Report Number
    MW5018440
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 23, 2010
    Report Date
    December 1, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DEPUY MITEK VAPR S 90 ELECTRODE DISTAL END SPARKED AND MELTED WHEN IN USE AT (B)(6). THIS IS THE SECOND OCCURRENCE OF THIS TYPE OF FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY MITEK INC. ELECTRODE MLN DEPUY MITEK VAPR S 90

    Patients

    Seq Age Sex Outcome Treatment
    1