BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT EXACT RETROPUBIC SYSTEM

    MDR report key: 23383978 · Received October 24, 2025

    Report

    Report Number
    3003990090-2025-01673
    Event Type
    Injury
    Date Received
    October 24, 2025
    Date of Event
    May 12, 2025
    Report Date
    December 10, 2025
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    OTN
    PMA / PMN Number
    K201686
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4, D5, G2, H4, H6 (INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS), H11. CORRECTION H6 (COMPONENT CODE). 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 DEVICE LOT NUMBER 3944845 (PRODUCT CODE TVTRL), AND (B)(6) WAS FOUND. NR REVIEWER HAS REVIEWED THE NR FILE AND HAS CONCLUDED, BASED ON THE INFORMATION AVAILABLE IN THE NR FILE, THAT (B)(6) IS NOT RELATED TO THE REPORTED COMPLAINT CONDITION OR IDENTIFIED MALFUNCTION. EXPIRATION DATE: 30.APR.2025 MANUFACTURING DATE: 22.MAY.2024" 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 RESULTS WILL BE REPORTED. THE MANUFACTURING NUMBER IS (B)(4).

    Description of Event or Problem · 0

    DIR (B)(4) RECEIVED FROM TGA REGARDING THE ETHICON PROSTHESIS FOR INCONTINENCE. PRODUCT DETAILS: - DEVICE: TVT EXACT RETROPUBIC MID-URETHRAL SLING. - DATE OF IMPLANTATION: (B)(6) 2025. THE PATIENT DEVELOPED PAIN AND TISSUE EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577042 TVT EXACT RETROPUBIC SYSTEM TVT-CAL-EXACT OTN CALDERA MEDICAL INC. TVTRL 3944845

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention