BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF-THREADING MONOKA

    MDR report key: 6961449 · Received October 19, 2017

    Report

    Report Number
    6961449
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Date of Event
    August 8, 2017
    Report Date
    September 21, 2017
    Manufacturer
    CLINICAL RESEARCH CONSULTANTS, INC.
    Product Code
    LZU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTEDLY NOTED PRIOR TO OPERATIVE PROCEDURE THAT THE STERILIZATION INDICATOR DOTS LOCATED ON UNOPENED MONOKA RITLENG STENT PACKAGING INDICATED THAT THE STENTS WERE NOT STERILE. THE DATE LOCATED ON THE PACKAGE INDICATED THAT IT WAS STILL STERILE. TWO PACKAGES WITH DIFFERENT LOT NUMBERS WERE NOTED TO BE EXPIRED BY THE COLOR OF THE DOT. THESE PACKAGES WERE REMOVED FROM STOCK AND GIVEN TO THE OR MATERIALS MANAGEMENT FOR FOLLOW UP. NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742648 SELF-THREADING MONOKA PLUG, PUNCTUM LZU CLINICAL RESEARCH CONSULTANTS, INC. S1-1800U 1554385

    Patients

    Seq Age Sex Outcome Treatment
    1