BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDI-STIM QUICK FIT PROBE

    MDR report key: 2412921 · Received December 29, 2011

    Report

    Report Number
    2412921
    Event Type
    Malfunction
    Date Received
    December 29, 2011
    Date of Event
    July 25, 2011
    Report Date
    October 7, 2011
    Manufacturer
    MEDISTIM USA INC.
    Product Code
    DPW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE ARE 4 3MM MEDSTIM PROBES AND 2 2MM PROBES THAT HAVE BROKEN. THEY ARE QUITE FRAGILE AND THOUGH MANUFACTURER SAYS AUTOCLAVEABLE, THEY BREAK DURING THE PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-STIM QUICK FIT PROBE GRAFT PATENCY DEVICE DPW MEDISTIM USA INC. PQ10032 *
    2 MEDI-STIM QUICKFIT PROBE GRAFT PATENCY DEVICE DPW MEDISTIM USA PQ100022 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *