BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TVT-CAL-EXACT

    MDR report key: 22821918 · Received August 15, 2025

    Report

    Report Number
    3003990090-2025-01603
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Report Date
    August 15, 2025
    Manufacturer
    CALDERA MEDICAL
    Product Code
    OTN
    PMA / PMN Number
    K201686
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DESIGN HISTORY FILE FOR THE LOT NUMBER SHOWED NO ANOMALIES OR DEVIATIONS WERE IDENTIFIED, AND THE DEVICE WAS CONFIRMED TO MEET ALL DESIGN AND MANUFACTURING SPECIFICATIONS. NO ISSUES FOUND THAT COULD BE ASSOCIATED WITH THE REPORTED SYMPTOMS. BASED ON THE LIMITED INFORMATION, THE COMPLAINT COULD NOT BE CONFIRMED AS RELATED TO DEVICE DEFICIENCY.

    Description of Event or Problem · 0

    THE PATIENT HAS HAD 4 VAGINAL DELIVERIES, A PROMONTOFIXATION WITH TOT IMPLANTATION ON DATE 1, AND A CURE OF CYSTOCELE VIA THE VAGINAL ROUTE WITH TVT IMPLANTATION ON DATE 2. SHE UNDERWENT AN EXCISION OF THE TAPE VIA CYSTOSCOPY ON DATE 3 DUE TO VESICAL PAIN AT THE END OF MICTURITION POSTOPERATIVELY. ON DATE 4, RECURRENCE OF SYMPTOMS WITH EXPOSURE OF THE TAPE AT CYSTOSCOPY LEADING TO AN EXCISION BY TRANSVESICAL AND CYSTOSCOPIC LAPAROSCOPY, FOLLOWED BY THE EXCISION OF REMNANTS OF THE TRANSVESICAL TAPE BY CYSTOSCOPY AND SECTIONING OF THE ANTERIOR VAGINAL TAPE ON DATE 5. ON DATE 6, THE PATIENT CONSULTED AGAIN FOR PELVIC PAIN AND URGENCY. CLINICALLY AND VIA MRI, THERE WAS A RETRACTION IN THE AREA OF THE PROSTHESES. REMOVAL OF THE PROMONTOFIXATION PROSTHESES BY ROBOT-ASSISTED LAPAROSCOPY WAS PERFORMED ON DATE 7. SUBSEQUENTLY, THERE WAS A PERSISTENCE OF DISABLING VAGINAL PAIN AND RECURRENCE OF URINARY STRESS INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2413144 TVT-CAL-EXACT TVT EXACT RETROPUBIC SYSTEM OTN CALDERA MEDICAL 3931916

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other