BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETACHABLE NYLON BAG 3X6 5/CSC

    MDR report key: 11228745 · Received January 26, 2021

    Report

    Report Number
    3007216334-2021-00021
    Event Type
    Injury
    Date Received
    January 26, 2021
    Date of Event
    January 4, 2021
    Report Date
    January 26, 2021
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A VOLUNTARY DISTRIBUTOR REPORT. THE MANUFACTURER, UNIMAX MEDICAL SYSTEMS, IS RESPONSIBLE FOR PERFORMING THE EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THIS IS A VOLUNTARY DISTRIBUTOR REPORT THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SB1036 WAS BEING USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2021 WHEN IT WAS REPORTED "THAT IT IS DIFFICULT TO USE DUE TO ITS LACK OF PLIABILITY AND FLEXIBILITY, THE TOP PORTION OF THE BAG IS VERY THICK MAKING IT DIFFICULT TO REMOVE - EVEN WHEN EMPTY. THERE HAVE BEEN NUMEROUS TIMES THEY HAVE HAD TO ENLARGE THE INCISION IN ORDER TO REMOVE THE BACK". THE PROCEDURE WAS COMPLETED WITH NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO PATIENT'S INCISION INCREASED IN SIZE TO REMOVE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128469 DETACHABLE NYLON BAG 3X6 5/CSC LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ UNIMAX MEDICAL SYSTEMS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other