BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI ENDO POCKET BAG 3X4

    MDR report key: 7684834 · Received July 13, 2018

    Report

    Report Number
    3007216334-2018-00176
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Report Date
    July 13, 2018
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    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 CONMED CORPORATION.

    Description of Event or Problem · 1

    THIS IS A VOLUNTARY DISTRIBUTOR REPORT. THE SB534 DEVICE WAS RECEIVED AT CONMED AND EVALUATED. EVALUATION OF THE DEVICE FOUND A TEAR IN THE SPECIMEN BAG. NO INFORMATION REGARDING THE FACILITY, PATIENT OR PROCEDURE IS AVAILABLE. THIS REPORT IS BEING RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529920 MINI ENDO POCKET BAG 3X4 MINI ENDO POCKET BAG 3X4 GCJ UNIMAX MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1