BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO POUCH WITH MEMORY WIRE 3"X6"

    MDR report key: 6964936 · Received October 20, 2017

    Report

    Report Number
    3007216334-2017-00227
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    September 19, 2017
    Report Date
    October 20, 2017
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 (B)(4).

    Description of Event or Problem · 1

    THIS IS A VOLUNTARY DISTRIBUTOR REPORT. A (B)(4) SALES REPRESENTATIVE REPORTED ON BEHALF OF A USER FACILITY THAT THE PLASTIC SHIELD OF THE WIRE OF THE ENDO POUCH WITH MEMORY WIRE WAS TORN. THE DEVICE WAS DISCARDED AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED SURGICAL DELAYS OR PATIENT INJURY. THIS REPORT IS 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
    745084 ENDO POUCH WITH MEMORY WIRE 3"X6" ENDO POUCH GCJ UNIMAX MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1