BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETACHABLE NYLON SPECIMEN BAG 3" X 6"

    MDR report key: 6132996 · Received November 29, 2016

    Report

    Report Number
    3007216334-2016-00146
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    October 31, 2016
    Report Date
    November 2, 2016
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY, DURING A LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2016, "SPECIMEN BAG BROKE AT THE TETHER WHILE TRYING TO REMOVE SPECIMEN." THIS REPORT IS BEING FILED AS A SERIOUS INJURY DUE TO LAPAROSCOPIC PROCEDURE CONVERTED TO OPEN DUE TO DEVICE BREAKAGE. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THIS EVENT OR PATIENT'S CURRENT STATUS. THIS REPORT IS BEING FILED BASED ON THE POTENTIAL FOR INJURY WITH RECURRENCE. THE COMPLAINT SAMPLE WAS DISPOSED OF BY THE USER FACILITY. THE LEGAL MANUFACTURER, UNIMAX MEDICAL SYSTEMS, INC., IS RESPONSIBLE FOR THE INVESTIGATION AND REGULATORY REPORTING PER AGREEMENT WITH CONMED CORPORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782638 DETACHABLE NYLON SPECIMEN BAG 3" X 6" SPECIMEN BAG GCJ UNIMAX MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention