BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPROSCOPIC CATHETER

    MDR report key: 4645468 · Received March 24, 2015

    Report

    Report Number
    MW5041729
    Event Type
    Malfunction
    Date Received
    March 24, 2015
    Date of Event
    March 9, 2015
    Report Date
    March 24, 2015
    Manufacturer
    AMERICAN CATHETER
    Product Code
    NWT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PACKAGING FOR DEVICE FOUND NOT SEALED AT MANUFACTURER. FOUND 11 MORE WITH SAME DEFECT IN STORE ROOM. DIAGNOSIS OR REASON FOR USE: CHOLANGIOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197613 LAPROSCOPIC CATHETER NWT AMERICAN CATHETER 14101601

    Patients

    Seq Age Sex Outcome Treatment
    1