BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 22005901 · Received May 12, 2025

    Report

    Report Number
    2210968-2025-05236
    Event Type
    Injury
    Date Received
    May 12, 2025
    Date of Event
    December 10, 2012
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT ANTERIOR/POSTERIOR REPAIR OF A PROLAPSE ON (B)(6) 2007 AND MESH WAS IMPLANTED. IN 2024, THE PATIENT REACHED OUT TO THE DOCTOR ABOUT IF A PESSARY COULD HELP, AS THE PATIENT STILL SUFFERED FROM PROLAPSE, BLOATING, URINARY TRACT INFECTIONS AND INCONTINENCE. THE DOCTOR WROTE THAT A PESSARY WOULD NOT HELP AND THAT THE PATIENT WOULD REQUIRE SURGERY AGAIN. THE PATIENT SAW A PRIVATE PELVIC PHYSIOTHERAPIST, WHO SPECIALIZED IN PESSARIES. ON THE FIRST APPOINTMENT, THE PATIENT WAS FITTED WITH A PESSARY. THE PATIENT HAD 4 FOLLOW-UP APPOINTMENTS WITH THE PHYSIOTHERAPIST BEFORE THE LOCAL GP TOOK OVER THE LONG TERM CARE OF THE PESSARY. THE PATIENT REPORTED NO LONGER SUFFERING FROM PROLAPSE, INCONTINENCE, UTIS OR SEVERE BLOATING. THE PATIENT STILL HAS SOME BLOATING AND PELVIC NERVE PAIN WHEN MOVING QUICKLY OR HAVE A JOLT. NO FURTHER INFORMATION COULD BE REQUESTED AS THE EVENT WAS REPORTED IN CONFIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371242 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention