BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 9334536 · Received November 18, 2019

    Report

    Report Number
    2210968-2019-90015
    Event Type
    Malfunction
    Date Received
    November 18, 2019
    Date of Event
    October 29, 2019
    Report Date
    November 2, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031000346
    PMA / PMN Number
    K033568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA FOR LOT 3933399 AND PRODUCT CODE 810081. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE EXPLAIN WHAT IS MEANT BY PACKAGE SEEMS DAMAGED? PLEASE CLARIFY, DEVICE DISCARDED DUE TO ASEPTIC ISSUE. IF THERE WAS NO HOLE OR TEAR IN THE PRIMARY PACKAGE WAS THE ASEPTIC ISSUE DUE USER HANDLING OF THE DEVICE? WAS THE PRIMARY PACKAGE DAMAGED, IF YES PROVIDE THE FOLLOWING? DID THE PRIMARY PACKAGE HAVE A HOLE, TEAR OR PUNCTURE EXPOSING THE DEVICE TO THE ENVIRONMENT IMPACTING THE DEVICES STERILITY? WAS THE PACKAGING REC'D DAMAGED OR WAS IT A RESULT OF STORAGE AND HANDLING? EVENT OCCURRED PREOP, HOW WAS THE PROCEDURE COMPLETED, WAS ANOTHER DEVICE OPENED?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SLING SURGERY ON (B)(6) 2019 AND THE MESH WAS IMPLANTED. THE PACKAGE FOUND TO BE DAMAGED AND DISCARDED DUE TO ASEPTIC ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132903 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3933399 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1