BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 8629212 · Received May 21, 2019

    Report

    Report Number
    2210968-2019-81609
    Event Type
    Malfunction
    Date Received
    May 21, 2019
    Date of Event
    January 1, 2019
    Report Date
    April 24, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031000346
    PMA / PMN Number
    K033568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUMMARY: ONE EMPTY OPENED BLISTER WITH THE LID IDENTIFIED WITH LOT NUMBER 3932675 AND PRODUCT CODE 810081 RECEIVED FOR EVALUATION. THE MESH WAS NOT RETURNED FOR EVALUATION. THE DEVICE (MESH) WAS REMOVED FROM THE BLISTER. THE BLISTER RECEIVED WAS MANIPULATED: THE BLISTER WAS OPENED. PARTICLES OF BLUE MESH ARE VISIBLE IN THE BLISTER. HOWEVER, THIS DEFECT IS NOT LINKED TO A MANUFACTURING ISSUE, THESE PARTICLES ARE DUE TO THE MANIPULATION AND CUTTING METHOD OF MESH (MANUAL CUTTING FOR PRODUCT CODE 810081). ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: IT WAS STATED IN THE DESCRIPTION THAT THE MESH MAY HAVE TO BE TAKEN OUT AND THE PROCEDURE POSSIBLY REDONE, WAS THE MESH TAKEN OUT AND/OR THE PROCEDURE REDONE? MESH WAS NOT TAKEN OUT. HOW IS THE PATIENT TODAY? WAITING TO COME BACK FOR POST OP REVIEW. WAS ANY INTERVENTION NEEDED OR TREATMENT RENDERED? NO. DID THE MESH HAVE ANY HOLES OR TEARS IN IT? NO.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. 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. IT WAS STATED IN THE DESCRIPTION THAT THE MESH MAY HAVE TO BE TAKEN OUT AND THE PROCEDURE POSSIBLY REDONE, WAS THE MESH TAKEN OUT AND/OR THE PROCEDURE REDONE? HOW IS THE PATIENT TODAY? WAS ANY INTERVENTION NEEDED OR TREATMENT RENDERED? DID THE MESH HAVE ANY HOLES OR TEARS IN IT? IT WAS REPORTED THAT "DR. MENTIONED THAT THIS IS NOT THE FIRST TIME SEEING LOOSE/DISINTEGRATED PROLENE MESH OUT FROM THE SLING". PLEASE PROVIDE A PRODUCT COMPLAINT NUMBER IF PREVIOUS EVENT WAS ALREADY REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN GYNECOLOGICAL PROCEDURE ON UNKNOWN DATE AND THE MESH WAS IMPLANTED. IT WAS REPORTED WHEN THE MESH WAS TAKEN OUT FROM STERILE PACK, A LOOSE/DISINTEGRATED PIECE OF MESH WAS OBSERVED AND THERE WAS A CONCERN IF THIS MIGHT LOSE THE INTEGRITY OF THE MESH. THE IMPLANT HAS BEEN IMPLANTED IN THE PATIENT. THE PATIENT IS UNDER MONITORING AND OBSERVATION IF THE MESH NEEDS TO BE TAKEN OUT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422303 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3932675 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1