BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP

    MDR report key: 4091520 · Received August 20, 2014

    Report

    Report Number
    4091520
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 20, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    TWO TROCARS WERE USED AND BOTH TIMES THE BALLOON ON THE TROCAR WOULD NOT INFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500638 SPACEMAKER BLUNT TIP TROCAR GCJ COVIDIEN OMS-T10BT P4B0273X, P3K0784X

    Patients

    Seq Age Sex Outcome Treatment
    1 *