BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIMEN BAG 3"X6" ATTACHED MEMORY WIRE

    MDR report key: 6132854 · Received November 29, 2016

    Report

    Report Number
    3007216334-2016-00144
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 31, 2016
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY, ON (B)(6) 2016, DURING A LAPAROSCOPIC APPENDECTOMY, "SPECIMEN BAG TETHER BROKE WHILE ATTEMPTING TO PULL BAG THROUGH FASCIA. THIS RESULTED IN A POST-OP INFECTION THAT REQUIRED THE PATIENT TO BE RE-ADMITTED AND HOSPITALIZED FOR 12 DAYS DUE TO A POST-OP INFECTION. AS OF THIS FILING, THE DATE OF PATIENT RELEASE POST-APPENDECTOMY AND THE DATE THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL FOR POST-OP INFECTION HAS NOT YET BEEN PROVIDED. THE COMPLAINT SAMPLE WAS DISPOSED OF BY THE USER FACILITY. THE LEGAL MANUFACTURER, (B)(4), IS RESPONSIBLE FOR THE INVESTIGATION AND REGULATORY REPORTING PER AGREEMENT WITH CONMED CORPORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783500 SPECIMEN BAG 3"X6" ATTACHED MEMORY WIRE SPECIMEN BAG GCJ UNIMAX MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization