BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI ENDO POCKET BAG 3X4

    MDR report key: 7483969 · Received May 3, 2018

    Report

    Report Number
    3007216334-2018-00106
    Event Type
    Injury
    Date Received
    May 3, 2018
    Date of Event
    April 4, 2018
    Report Date
    May 3, 2018
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER UNIMAX MEDICAL SYSTEMS, INC. IS RESPONSIBLE FOR PERFORMING EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE PER AGREEMENT WITH (B)(4).

    Description of Event or Problem · 1

    THIS IS A VOLUNTARY DISTRIBUTOR REPORT. THE (B)(4) SALES REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT DURING A PROCEDURE, WHILE REMOVING NODES, THE SB534 BAG BROKE. UPON ATTEMPTS TO GATHER ADDITIONAL INFORMATION, THE REPORTER STATED THAT ALTHOUGH UNSURE OF HIS RECOLLECTION OF THE EVENTS, ONE PROCEDURE REQUIRED THE INITIAL INCISION TO BE WIDENED TO PULL THE SPECIMEN OUT. NO PROCEDURAL DELAY OR PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION REGARDING THE CURRENT PATIENT STATUS OR PROCEDURE WAS PROVIDED. DUE TO THE INCISION NEEDING TO BE WIDENED TO COMPLETE THE PROCEDURE, THIS INCIDENT IS RAISED BASED ON A PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326788 MINI ENDO POCKET BAG 3X4 SPECIMEN BAGS GCJ UNIMAX MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other