BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPY PACK

    MDR report key: 6308347 · Received February 3, 2017

    Report

    Report Number
    MW5067718
    Event Type
    Malfunction
    Date Received
    February 3, 2017
    Report Date
    February 3, 2017
    Manufacturer
    CARDINAL
    Product Code
    FDE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SMALL DEAD BUGS FOUND IN STERILE CUSTOM KIT. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83832 LAPAROSCOPY PACK LAPAROSCOPY PACK FDE CARDINAL LAPAROSCOPY PACK 570929

    Patients

    Seq Age Sex Outcome Treatment
    1