BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DETACHABLE POUCH 3X6

    MDR report key: 6731451 · Received July 21, 2017

    Report

    Report Number
    3007216334-2017-00166
    Event Type
    Malfunction
    Date Received
    July 21, 2017
    Report Date
    July 21, 2017
    Manufacturer
    UNIMAX MEDICAL SYSTEMS INC
    Product Code
    GCJ
    PMA / PMN Number
    K103510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A VOLUNTARY DISTRIBUTOR REPORT. 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 CONMED CORPORATION.

    Description of Event or Problem · 1

    THIS IS A VOLUNTARY DISTRIBUTOR REPORT. THE USER FACILITY CONTACTED A CONMED SALES REPRESENTATIVE TO REPORT FOUR INCIDENCES OF ITEM SB936- SPECIMEN BAG BREAKING INTRAOPERATIVELY DURING SURGERY BETWEEN (B)(6) 2016. AS REPORTED, THE TETHER ON THE BAG BROKE BUT THE BAG MAINTAINED INTACT. THE USER RETRIEVED THE BAG AND THE SPECIMEN DID NOT FALL INTO THE PATIENT. NO PATIENT INJURY, SURGICAL DELAY OR EXTENDED HOSPITAL STAY WAS REPORTED. THE COMPLAINT DEVICE WAS DISPOSED OF BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514167 DETACHABLE POUCH 3X6 SPECIMEN BAGS GCJ UNIMAX MEDICAL SYSTEMS INC SB936

    Patients

    Seq Age Sex Outcome Treatment
    1