BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETACHABLE POUCH 5X7" 5EA/BOX

    MDR report key: 12664014 · Received October 20, 2021

    Report

    Report Number
    3007216334-2021-00305
    Event Type
    Injury
    Date Received
    October 20, 2021
    Date of Event
    September 24, 2021
    Report Date
    October 20, 2021
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SB957, DETACHABLE POUCH 5X7" 5EA/BOX, WAS USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021 WHEN IT WAS REPORTED ¿DURING THE EXTRACTION MANEUVERS OF THE BAG CONTAINING THE ANATOMICAL PIECE, THE BAG BROKE, RELEASING PLASTIC MATERIAL IN THE THORACIC CAVITY¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT ANSWERS WERE REQUESTED OF THE REPORTER; HOWEVER, TO DATE WE HAVE NOT RECEIVED A RESPONSE. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO UNKNOWN LOCATION OF DEVICE COMPONENT AND WILL BE FILED AS A VOLUNTARY DISTRIBUTOR REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565917 DETACHABLE POUCH 5X7" 5EA/BOX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ UNIMAX MEDICAL SYSTEMS, INC. 6252010113

    Patients

    Seq Age Sex Outcome Treatment
    1 Other