BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIMAX DETACHABLE POUCH

    MDR report key: 8975259 · Received September 9, 2019

    Report

    Report Number
    3007216334-2019-00322
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Date of Event
    August 23, 2019
    Report Date
    September 9, 2019
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VOLUNTARY 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. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    VOLUNTARY DISTRIBUTOR REPORT: THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE FACILITY THAT THE SB936, UNIMAX SPECIMEN BAG, BROKE DURING A PROCEDURE WHILE CINCHING THE BAG CLOSED. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS A 1-2 MINUTE DELAY REPORTED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER OF THE SAME SPECIMEN BAG. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768550 UNIMAX DETACHABLE POUCH SPECIMEN BAG GCJ UNIMAX MEDICAL SYSTEMS, INC. 8251901155

    Patients

    Seq Age Sex Outcome Treatment
    1