BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT EXACT RETROPUBIC SYSTEM

    MDR report key: 23363719 · Received October 22, 2025

    Report

    Report Number
    3003990090-2025-01655
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    August 6, 2025
    Report Date
    October 22, 2025
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    OTN
    PMA / PMN Number
    K132054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE CONDUCTED BECAUSE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. HOWEVER, A REVIEW OF THE MANUFACTURING RECORDS FOR THE FINISHED DEVICE LOT NUMBER WAS CARRIED OUT, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. AS PART OF ETHICON'S QUALITY CONTROL PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED ACCORDING TO APPROVED SPECIFICATIONS. ADDITIONALLY, WE WILL CONTINUE TO MONITOR COMPLAINT INFORMATION FOR POTENTIAL SAFETY SIGNALS THROUGH COMPLAINT TRENDING AS PART OF OUR POST-MARKET SURVEILLANCE. IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED ACCORDINGLY. THE MANUFACTURING NUMBER IS C25-2815.

    Description of Event or Problem · 0

    CLINICAL TRIAL PATIENT ESC_2020_03 REPORTED POST-OPERATIVE URINARY RETENTION. THE RELATIONSHIP TO THE STUDY DEVICE IS UNLIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2777225 TVT EXACT RETROPUBIC SYSTEM TVT-CAL-EXACT OTN CALDERA MEDICAL INC. 810041BL 3944976

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention