BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBTURATOR W LASR

    MDR report key: 24075539 · Received January 14, 2026

    Report

    Report Number
    3003990090-2026-02007
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    August 30, 2025
    Report Date
    March 4, 2026
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    OTN
    UDI-DI
    10705031062306
    PMA / PMN Number
    K033568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4, H4, H6, H11 INVESTIGATION RESULTS: "AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. "A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED LOT NUMBER 3238455 (PRODUCT CODE 810081L), AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. EXPIRATION DATE: 31.OCT.2009 MANUFACTURING DATE : 19.NOV.2008" AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION, THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE ACTION IS REQUIRED AT THIS TIME. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE." THE MANUFACTURING NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING, AND THE RESULTS WILL BE REPORTED WHEN AVAILABLE. THE MANUFACTURING COMPLAINT'S NUMBER IS (B)(4).

    Description of Event or Problem · 0

    DIR 129257 RECEIVED FROM TGA IN RELATION TO GYNECARE TVT SYSTEM - TRANSOBTURATOR TAPE (MESH) - PROSTHESIS, INCONTINENCE PRODUCT DETAILS PROVIDED: 810081 PART NUMBER: 810081 LOT NUMBER: 3238455 DATE OF IMPLANTATION: (B)(6) 2009 DATE OF EXPLANATION: (B)(6) 2025 ON THE (B)(6) 2025 PATIENT WENT FOR INSERTION OF TVTO + CYSTOSCOPY + POSTERIOR VAGINAL WALL REPAIR + REFASHIONING OF LEFT MINORA. POST PROCEDURE PATIENT EXPERIENCED SLOW URINE FLOW AND FROM APPROXIMATELY 2021 SHE NOTED THERE WERE FEELINGS OF INCOMPLETE EMPTYING. PATIENT WAS ALSO EXPERIENCING PROGRESSIVE PAIN ON COITUS WITH BLEEDING LEADING TO NO COITUS FOR PAST 2 YEARS. PATIENT ALSO EXPERIENCED SOME GROIN PAIN. PATIENT WAS ALSO SUFFERING WITH RECURRENT UTIS AND REQUIRED CEFALEX PROPHYLAXIS. IN (B)(6) 2024, PATIENT HAD AN EXAMINATION UNDER ANESTHESIA, WHICH DEMONSTRATED A URETHRAL EROSION WITH STONE BUILDING INTO A DIVERTICULUM. THIS RESULTED IN THE PATIENT REQUIRING SURGERY AND ON THE (B)(6) 2025 PATIENT HAD A COMPLETE REMOVAL OF TRANSOBTURATOR SLING, URETHRAL RECONSTRUCTION AND CYSTOSCOPY. POST OPERATIVELY FROM TVTO REMOVAL PATIENT HAD FEVERS LIKELY DUE TO INFECTION/COLONISATION OF TVTO AND LEFT FEMORAL NERVE NEUROPRAXIA SECONDARY TO INFLAMMATION ADJACENT TO LEFT GRACILIS WITH WEAKNESS IN LEFT HIP ADDUCTION AND FLEXION WHICH HAS NOW SIGNIFICANTLY IMPROVED. PATIENT HISTORY: HT; GORD; T2DM; HIGH CHOL PATIENT OUTCOME/CONSEQUENCES: N/A DISCLAIMER NO FURTHER INFORMATION AVAILABLE AS REPORTER DETAILS HAVE NOT BEEN DISCLOSED (CONFIDENTIAL)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129105 GYNECARE TVT OBTURATOR W LASR TVT-CAL-RETROPUBIC OTN CALDERA MEDICAL INC. 3238455 10705031062306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention