BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RING, SILASTIC

    MDR report key: 6010864 · Received October 7, 2016

    Report

    Report Number
    6010864
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    August 26, 2016
    Report Date
    September 6, 2016
    Manufacturer
    BENTEC MEDICAL
    Product Code
    GBX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A LAPAROSCOPIC VERTICAL ROUX-EN-Y GASTRIC BYPASS WITH SILASTIC RING PLACED APPROXIMATELY TWO YEARS AGO. PATIENT PRESENTED TO THE PHYSICIAN OFFICE THIS SUMMER TO REVIEW AN EGD THAT WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661897 RING, SILASTIC GBX BENTEC MEDICAL GS75160-48 SP8 1416205

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other