BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETACHABLE POUCH 3X6" 5EA/BOX

    MDR report key: 13051601 · Received December 21, 2021

    Report

    Report Number
    3007216334-2021-00312
    Event Type
    Injury
    Date Received
    December 21, 2021
    Date of Event
    November 15, 2021
    Report Date
    December 21, 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 · 0

    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 · 0

    VOLUNTARY DISTRIBUTOR REPORT THE CUSTOMER REPORTED THAT THE DEVICE, SB936, DETACHABLE POUCH 3X6" 5EA/BOX WAS BEING USED ON (B)(6) 2021 DURING A CHOLECYSTECTOMY PROCEDURE AND ¿DURING THE EXTRACTION OF THE ENDO POCKET FROM THE UMBILICAL INCISION OCCURS THE RUPTURE OF THE BAG CREATING SERIOUS INCONVENIENCE FOR THE EXTRACTION OF THE GALLBLADDER THAT REQUIRED THE EXECUTION OF A LAPAROTOMY.¿ THERE WAS NO INJURY OR IMPACT TO THE PATIENT. FURTHER ASSESSMENT HAS BEEN SENT; HOWEVER, TO DATE NO DETAILS HAVE BEEN MADE AVAILABLE. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO CHANGING FROM A LAPAROSCOPIC PROCEDURE TO AN OPEN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955439 DETACHABLE POUCH 3X6" 5EA/BOX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ UNIMAX MEDICAL SYSTEMS, INC. 6252011040

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown