BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUMARK Q

    MDR report key: 6587291 · Received May 24, 2017

    Report

    Report Number
    1000408433-2017-00001
    Event Type
    Malfunction
    Date Received
    May 24, 2017
    Date of Event
    May 2, 2017
    Report Date
    May 24, 2017
    Manufacturer
    SOMATEX MEDICAL TECHNOLOGIES GMBH
    Product Code
    NEU
    UDI-DI
    04250195603081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STERILE PACKAGE WAS PUNCTURED. THE CANNULA SYSTEMS OF THIS PRODUCT CODE ARE PACKAGED IN SOFT BLISTERS. THERE IS A PROTECTIVE TUBE OVER THE CANNULA TO PREVENT THE RISK OF PUNCTURE OF THE PACKAGING MATERIAL. ONE PROTECTIVE TUBE DETACHED FROM THE CANNULA AND THE CANNULA PUNCTURED THE PACKAGE. THE PACKAGING OF THE PRODUCT WAS PUNCTURED, WHICH RESULTED IN THE PRODUCT BEING NON-STERILE. THE COMPLAINED PRODUCT HAS NOT BEEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368524 TUMARK Q TUMARK Q NEU SOMATEX MEDICAL TECHNOLOGIES GMBH TUMARK Q 47910 04250195603081

    Patients

    Seq Age Sex Outcome Treatment
    1