BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 12927056 · Received December 3, 2021

    Report

    Report Number
    2210968-2021-12340
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    October 27, 2021
    Report Date
    May 16, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031000346
    PMA / PMN Number
    K033568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO FDA: 05/16/2022. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION: H6.

    Additional Manufacturer Narrative · 0

    (B)(4). A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA FOR LOT 3939296 AND PRODUCT CODE 810081. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ¿ PLEASE CLARIFY, WERE THERE ANY PATIENT CONSEQUENCES? DURING THE PROCEDURE THERE WERE NONE. BUT DR. THINKS THAT IN THE LONG TERM INCONTINENCE CAN RECUR. ¿ IF YES, WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED? THE SURGICAL PLAN WAS CONTINUED ACCORDING TO THE TECHNIQUE AND THE PROLENE MESH WAS CORRECTLY PLACED UNDER THE URETHRA. ¿ ARE THERE ANY PLANS TO REMOVE THE DEVICE? NOT FOR THE MOMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGICAL PROCEDURE ON (B)(6) 2021 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PROLENE OF THE TAPE THAT REMAINED IN CONTACT WITH THE PATIENT HAD VERY LITTLE GOOD SURFACE, SINCE A NETWORK OF THREE LINES OF THREADS REMAINED AFTER PASSING THROUGH THE OBTURATOR MEMBRANE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820431 GYNECARE TVT OBTURATOR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 810081 3939296 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1 Female