BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETACHABLE POUCH 3X6

    MDR report key: 6257528 · Received January 17, 2017

    Report

    Report Number
    3007216334-2016-00166
    Event Type
    Injury
    Date Received
    January 17, 2017
    Date of Event
    December 21, 2016
    Report Date
    January 17, 2017
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY, DURING A LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2016, "BAG BROKE AND BILE SPILLED INTO THE ABDOMEN, PATIENT HAD TO BE ADMITTED TO THE ICU. FOLLOW UP WITH FACILITY REVEALED THAT THERE WERE TWO (2) SB936 DEVICES UTILIZED ON THIS PATIENT. THE DEVICE BROKE BEFORE THE SPECIMEN WAS PLACED IN THE BAG. A SECOND DEVICE WAS THEN UTILIZED AND BROKE AFTER THE SPECIMEN WAS PLACED IN THE BAG, CAUSING THE ADMISSION TO THE ICU. BOTH DEVICES WERE RECEIVED AT CONMED CORPORATION ON (B)(6) 2017. THE EVALUATION OF DEVICES REVEALED THE DEVICES HAD TWO (2) DIFFERENT LOT NUMBERS, 8251608190 AND 8251605091. IT IS UNKNOWN WHICH LOT BELONGS TO WHICH DEVICE. THERE ARE TWO (2) COMPLAINT RECORDS ASSOCIATED WITH THIS COMPLAINT, THIS (B)(4). ALTHOUGH MULTIPLE ATTEMPTS HAVE BEEN MADE, TO DATE THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING CLARIFICATION OF DEVICES USED OR THE PATIENT'S CURRENT CONDITION. THE DEVICES AND ALL INFORMATION OBTAINED HAS BEEN FORWARDED TO THE LEGAL MANUFACTURER, (B)(4) , WHO IS RESPONSIBLE FOR THE INVESTIGATION AND REGULATORY REPORTING. A SUPPLIER CORRECTIVE ACTION REQUEST HAS BEEN ISSUED, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40311 DETACHABLE POUCH 3X6 SPECIMEN BAG GCJ UNIMAX MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization