BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIMAX DETACHABLE NYLON SPECIMEN BAG

    MDR report key: 8180161 · Received December 19, 2018

    Report

    Report Number
    3007216334-2018-00294
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    December 3, 2018
    Report Date
    December 19, 2018
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    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 AN EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED ISSUE PER AGREEMENT WITH CONMED CORPORATION.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A VOLUNTARY DISTRIBUTOR REPORT. THE CUSTOMER REPORTED THAT THE SB1036, UNIMAX SPECIMEN BAG, RIPPED DURING THE EXTRACTION PHASE OF A HYSTERECTOMY. THE ATTENDING SURGEON WAS TRYING TO REMOVE THE BAG THROUGH THE INCISION SITE WHEN THE BAG RIPPED ALONG THE TOP SEAM. HE WAS USING THE STRINGS TO PULL ON THE BAG. THE PROCEDURE WAS COMPLETED WITH NO NEED FOR ANOTHER DEVICE. THERE IS NO REPORTED INJURY OR SURGICAL DELAY. THIS WAS AN EVALUATION OF A NEW DEVICE FOR THE FACILITY. THIS WAS THE FIRST TIME THEY HAD USED THIS PRODUCT. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021868 UNIMAX DETACHABLE NYLON SPECIMEN BAG SPECIMEN BAG GCJ UNIMAX MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1