BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADDISON II

    MDR report key: 27163 · Received October 18, 1995

    Report

    Report Number
    MW1007353
    Event Type
    Malfunction
    Date Received
    October 18, 1995
    Date of Event
    September 28, 1995
    Report Date
    October 3, 1995
    Manufacturer
    ELMED INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    PIECE OF TEFLON TIP ON PROBE SHEARED OFF WHILE PASSING THROUGH TROCAR. PIECE NOT FOUND DURING SURGERY. RPTR HAS HAD CONTACT WITH MFR RE INCIDENT. RPTR IS UNAWARE OF ANY INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADDISON II PROPE WITH ATTACHED TEFLON TIP GEI ELMED INC. 52205-51

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR