BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIMAX DETACHABLE POUCH 3X6

    MDR report key: 8623400 · Received May 20, 2019

    Report

    Report Number
    3007216334-2019-00166
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    April 24, 2019
    Report Date
    May 20, 2019
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    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 (B)(4) 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 (B)(4) REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SB936, UNIMAX DETACHABLE POUCH, BROKE INSIDE A PATIENT WHILE PERFORMING A VATS PROCEDURE ON (B)(6) 2019. THE SPECIMEN WITH CANCER MARGINS WAS LEFT INSIDE THE PATIENT'S ABDOMEN UNTIL ANOTHER BAG COULD BE DEPLOYED. THE 2ND BAG RETRIEVED THE SPECIMEN. THERE WAS A 5-MINUTE DELAY IN SURGERY. THERE WAS NO REPORTED INJURY TO THE PATIENT AND THE PROCEDURE WAS COMPLETED AS PLANNED. THIS REPORT IS BEING RAISED AS A VOLUNTARY DISTRIBUTOR REPORT DUE TO DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417492 UNIMAX DETACHABLE POUCH 3X6 SPECIMEN BAG GCJ UNIMAX MEDICAL SYSTEMS, INC. 8251810091

    Patients

    Seq Age Sex Outcome Treatment
    1