BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK PROBE DRAPE

    MDR report key: 1652483 · Received April 6, 2010

    Report

    Report Number
    1043582-2010-00001
    Event Type
    Malfunction
    Date Received
    April 6, 2010
    Date of Event
    February 7, 2010
    Report Date
    February 10, 2010
    Manufacturer
    MICROTEK MEDICAL, INC.
    Product Code
    KKX
    PMA / PMN Number
    K050322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING OR AFTER THE PROCEDURE, IT WAS NOTED THAT THERE WAS A TEAR IN THE PROBE COVER WHERE THE LATEX MEETS THE PLASTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTEK PROBE DRAPE T SHAPED PROBE DRAPE KKX MICROTEK MEDICAL, INC. PC3687 D92101

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK