BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIMAX MINI ENDO POCKET BAG 3X4

    MDR report key: 6581209 · Received May 22, 2017

    Report

    Report Number
    3007216334-2017-00106
    Event Type
    Injury
    Date Received
    May 22, 2017
    Date of Event
    May 2, 2017
    Report Date
    May 22, 2017
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY, ON (B)(6) 2017 DURING A LAPAROSCOPIC APPENDECTOMY, THE SB534 UNIMAX MINI ENDO POCKET BAG 3X4 SPLIT DOWN THE SEAM WHEN REMOVING THE APPENDIX. THE SPECIMEN DROPPED BACK INTO THE ABDOMEN AND WAS RETRIEVED UTILIZING ANOTHER VENDOR'S SPECIMEN BAG. THERE WAS A MINIMAL SURGICAL DELAY OF THREE (3) MINUTES AND NO REPORTED PATIENT INJURY. TO DATE, NO FURTHER INFORMATION ON THE PATIENT'S CURRENT STATUS HAS BEEN PROVIDED. THIS REPORT IS BEING FILED BASED ON THE POTENTIAL FOR INJURY WITH RECURRENCE. THE LEGAL MANUFACTURER (B)(4) HAS THE COMPLAINT INVESTIGATION RESPONSIBILITY AND NOTIFICATION HAS BEEN SENT TO THE MANUFACTURER ON 2-MAY-2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363959 UNIMAX MINI ENDO POCKET BAG 3X4 LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ UNIMAX MEDICAL SYSTEMS, INC. 8251703194

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention