BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIMAX ENDO POUCH WITH MEMORY WIRE 3X6

    MDR report key: 9342333 · Received November 19, 2019

    Report

    Report Number
    3007216334-2019-00395
    Event Type
    Malfunction
    Date Received
    November 19, 2019
    Date of Event
    November 1, 2019
    Report Date
    November 19, 2019
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VOLUNTARY DISTRIBUTOR NARRATIVE: 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. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THIS IS A VOLUNTARY DISTRIBUTOR REPORT: CONMED (B)(6) REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE SB836, UNIMAX ENDO POUCH'S, GREEN TIPS DROPPED INTO THE BODY WHEN USED. THE GREEN TIPS WERE SUCCESSFULLY REMOVED. THERE WAS NO REPORTED DELAY. THERE WAS NO REPORTED PATIENT INJURY OR IMPACT. UNIMAX, THE VENDOR, IS RESPONSIBLE FOR EVALUATION, INVESTIGATION AND REPORTING TO THE HEALTH AUTHORITIES. THIS IS DEEMED A REPORTABLE EVENT PER CONMED AND WILL BE REPORTED AS A VOLUNTARY DISTRIBUTOR REPORT. 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
    1138867 UNIMAX ENDO POUCH WITH MEMORY WIRE 3X6 SPECIMEN BAG GCJ UNIMAX MEDICAL SYSTEMS, INC. 8251810090

    Patients

    Seq Age Sex Outcome Treatment
    1