BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBTURATOR W LASR

    MDR report key: 24236477 · Received February 2, 2026

    Report

    Report Number
    3003990090-2026-02024
    Event Type
    Injury
    Date Received
    February 2, 2026
    Date of Event
    October 27, 2025
    Report Date
    March 13, 2026
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    OTN
    UDI-DI
    10705031062306
    PMA / PMN Number
    K033568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 3944988 (PRODUCT CODE 810081L), AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. EXPIRATION DATE: 28.FEB.2026 MANUFACTURING DATE : 26.MAR.2025" 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 C26-3021.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING AND THE RESULTS WILL BE REPORTED SOON. THE INTERNAL MANUFACTURE'S COMPLAINT NUMBER IS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED LEG, PELVIS, HIP, LOWER BACK, PAINFUL LEFT, BURN VERY COMPLICATED TO PUT FOOT ON THE FLOOR, COMPLICATION FOR WALKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292277 GYNECARE TVT OBTURATOR W LASR TVT-CAL-OBTURATOR OTN CALDERA MEDICAL INC. 810081L 3944988 10705031062306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention