BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DETACHABLE POUCH 3X6

    MDR report key: 7486954 · Received May 4, 2018

    Report

    Report Number
    3007216334-2018-00108
    Event Type
    Malfunction
    Date Received
    May 4, 2018
    Date of Event
    April 10, 2018
    Report Date
    May 4, 2018
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR NARRATIVE: THE MANUFACTURER UNIMAX MEDICAL SYSTEMS, INC. IS RESPONSIBLE FOR PERFORMING EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE PER AGREEMENT WITH CONMED CORPORATION.

    Description of Event or Problem · 1

    THIS IS A VOLUNTARY DISTRIBUTOR REPORT: THE CONMED SALES REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT DURING A PROCEDURE, A SB534 MINI ENDO POCKET BAG BROKE WHILE TRYING TO REMOVE A NODE; THEREFORE, THE USER ATTEMPTED TO COMPLETE THE PROCEDURE WITH AN ALTERNATE SB936 DETACHABLE POUCH, WHICH ALSO BROKE. UPON ATTEMPTS TO GATHER ADDITIONAL INFORMATION, THE REPORTER STATED THAT ALTHOUGH UNSURE OF HIS RECOLLECTION OF THE EVENTS, THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION REGARDING THE CURRENT PATIENT STATUS OR PROCEDURE WAS PROVIDED. THIS REPORT IS BEING RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331573 DETACHABLE POUCH 3X6 SPECIMEN BAGS GCJ UNIMAX MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1