BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBTURATOR W LASR

    MDR report key: 21655439 · Received March 20, 2025

    Report

    Report Number
    2210968-2025-03007
    Event Type
    Injury
    Date Received
    March 20, 2025
    Date of Event
    January 1, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031062306
    PMA / PMN Number
    K033568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 INC, 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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: PLEASE PROVIDE THE PATIENT SYMPTOMS MANIFESTATIONS (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL REACTION): PLEASE CLARIFY THE CONSEQUENCES FOR THE PATIENT. WAS THERE ANY ASSOCIATED MEDICAL OR SURGICAL INTERVENTION TO TREAT ANY OF THE PATIENT CONSEQUENCES? IF SO, PLEASE CLARIFY. TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE IN 2009 AND MESH WAS IMPLANTED. 16 YEARS AFTER SURGERY, THE PATIENT EXPERIENCED NEW PROBLEMS OF URINARY INCONTINENCE, ACCOMPANIED BY SYMPTOMS SIMILAR TO THOSE BEFORE THE OPERATION. AMONG THE POSSIBLE CAUSES CURRENTLY UNDER CONSIDERATION, THERE HAS BEEN A HYPOTHESIS THAT THE BENDERELLES USED DURING THE INTERVENTION HAVE BEEN DEGRADED, A POSSIBILITY OF WHICH THE PATIENT HAD BEEN INFORMED BEFOREHAND PRECISELY BECAUSE OF THE TYPE OF INTERVENTION. IN PARTICULAR, BLUE/BLUE ELEMENTS HAVE BEEN DETECTED IN URINARY SEDIMENT FOLLOWING URINOCULTURE, WHICH MAY HAVE A CORRELATION WITH BENDERELLA. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451674 GYNECARE TVT OBTURATOR W LASR MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3335235 10705031062306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other