BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT-CAL-OBTURATOR

    MDR report key: 23022449 · Received September 10, 2025

    Report

    Report Number
    3003990090-2025-01611
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    August 18, 2025
    Report Date
    February 3, 2026
    Manufacturer
    CALDERA MEDICAL
    Product Code
    OTN
    UDI-DI
    10705031062306
    PMA / PMN Number
    K201686
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4, D5, E1, E3, G4, H4 ,H5 , 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 3944899 (PRODUCT CODE 810081L), AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. EXPIRATION DATE: 31.AUG.2025 MANUFACTURING DATE : 20.SEP.2024 AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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

    AN INVESTIGATION COULD NOT BE PERFORMED AS THE DEVICE IS NOT RETURNED. BASED ON THE LIMITED INFORMATION PROVIDED, THE REPORTED PRODUCT COMPLAINT COULD NOT BE CONFIRMED. A REVIEW OF GENERAL MANUFACTURING RECORDS INDICATES THAT ALL PRODUCTS RELEASED DURING THE RELEVANT TIMEFRAME WERE MANUFACTURED IN ACCORDANCE WITH APPROVED PROCEDURES AND MET ESTABLISHED SPECIFICATIONS DURING THE MANUFACTURING AND QUALITY RELEASE PROCESS.

    Description of Event or Problem · 0

    "PAIN ++ INSIDE LEFT THIGH WITH ALMOST IMPOSSIBLE TO WALK AFTER SURGERY. AT THE ECHO THE STRIP PASSES INTO THE ADDUCTOR. 1 TH SURGICAL RESUMPTION FOR PARTIAL REMOVAL DATE 1. PAIN IN THE BUTTOCKS INDICATING CONFLICT WITH OBTURATORS. 2TH RESUMED FOR NEW PARTIAL WITHDRAWAL ON DATE 2. ALWAYS PAINS ESPECIALLY LEFT BUTTOCK AT PROLONGED SITTING BUT ALSO AT THE LEVEL OF THE INSIDE OF THE LEFT THIGH AND AT WALKING SIMPLE MODERATE PAINS INSIDE THE LEFT THIGH RISING UP IN THE GROIN AND ACCENTUATED IN DESCENT OR UPHILL. VERY DISABLING PAIN. 4 MONTHS OF COMPLETE WORK STOPPAGE AND SINCE MID-JUNE RESUMPTION OF MY PROFESSIONAL ACTIVITY IN THERAPEUTIC HALF-TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061613 TVT-CAL-OBTURATOR "GYNECARE TVT OBTURATOR W LASR OTN CALDERA MEDICAL 810081L 3944899 10705031062306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other