BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETACHABLE NYLON BAG 3X6 5/CSC

    MDR report key: 11172826 · Received January 14, 2021

    Report

    Report Number
    3007216334-2021-00025
    Event Type
    Injury
    Date Received
    January 14, 2021
    Report Date
    January 14, 2021
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A VOLUNTARY DISTRIBUTOR REPORT. THE MANUFACTURER, UNIMAX MEDICAL SYSTEMS, INC., 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

    VOLUNTARY DISTRIBUTOR REPORT: THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SB1036, DETACHABLE NYLON BAG 3X6 5/CSC WAS BEING USED FOR AN UNKNOWN SURGERY ON AN UNKNOWN DAY AND IT WAS REPORTED THAT "THE PATIENT HAD TO RETURN TO SURGERY, NOT CLEAR ON WHY. REFERENCED AT ONE POINT THAT THE BAG WAS STICKY AND ALLEGEDLY COULD HAVE PULLED BOWEL WITH IT WHEN REMOVING SPECIMEN." THE PATIENT HAD PROLONGED HOSPITALIZATION AND THEIR CURRENT STATUS IS UNKNOWN. (B)(6) HOSPITAL CADILLAC HAS NOT RESPONDED TO REQUESTS FROM CONMED FOR MORE INFORMATION ON THE CAUSE OF THIS INCIDENT. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY AS THE PATIENT HAD TO RETURN TO SURGERY FOR UNKNOWN REASONS . NO OTHER PATIENT OUTCOME INFORMATION IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66610 DETACHABLE NYLON BAG 3X6 5/CSC LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ UNIMAX MEDICAL SYSTEMS, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization