BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TVT EXACT RETROPUBIC SYSTEM

    MDR report key: 23437583 · Received October 31, 2025

    Report

    Report Number
    3003990090-2025-01695
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 7, 2025
    Report Date
    December 17, 2025
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    OTN
    PMA / PMN Number
    K132054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4, D5, H4, H6, H11 CORRECTION: G2. 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 3944788 (PRODUCT CODE TVTRL), AND NR-0216971 WAS FOUND. NR REVIEWER HAS REVIEWED THE NR FILE AND HAS CONCLUDED, BASED ON THE INFORMATION AVAILABLE IN THE NR FILE, THAT NR-0216971 IS NOT RELATED TO THE REPORTED COMPLAINT CONDITION OR IDENTIFIED MALFUNCTION. EXPIRATION DATE: 31.JAN.2025 MANUFACTURING DATE: 14.FEB.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

    THIS REPORT IS BEING SUBMITTED IN ACCORDANCE WITH THE REQUIREMENTS OF 21 CFR PART 803. THE INFORMATION CONTAINED HEREIN IS BASED ON DATA AVAILABLE TO CALDERA MEDICAL AT THE TIME OF SUBMISSION AND MAY NOT HAVE BEEN FULLY INVESTIGATED OR INDEPENDENTLY VERIFIED PRIOR TO THE REQUIRED REPORTING DEADLINE. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR CONCLUSION BY CALDERA MEDICAL THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION REMAINS ONGOING. IN ACCORDANCE WITH MANUFACTURING PROCEDURES, TRAYS ARE INSPECTED AGAINST A BLACK BACKGROUND, AND NO PARTICLES WERE NOTED DURING THESE INSPECTIONS. A FINAL INSPECTION OF THE PRODUCT IS ALSO PERFORMED TO VERIFY PRODUCT INTEGRITY. ALL MESH DEVICES WERE STERILIZED USING ETHYLENE OXIDE, AND THE PRODUCTS WERE CONFIRMED TO MEET SPECIFICATIONS AT THE TIME OF RELEASE. A REVIEW OF THE MANUFACTURING RECORDS INDICATES THAT ALL PRODUCTS RELEASED DURING THE RELEVANT TIMEFRAME WERE MANUFACTURED IN ACCORDANCE WITH APPROVED PROCEDURES AND MET ALL ESTABLISHED SPECIFICATIONS DURING BOTH MANUFACTURING AND QUALITY RELEASE PROCESSES. AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION, NO DEFINITIVE CONCLUSIONS CAN BE DRAWN REGARDING THE REPORTED EVENT AT THIS TIME. THE INVESTIGATION WILL CONTINUE, AND THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. THE MANUFACTURING NUMBER IS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED BY DISTRIBUTOR PER HEALTHCARE PROFESSIONAL THAT THERE WAS WHITE POWDER/ DUST WITHIN THE STERILE PACKAGING. NO PATIENT HARM HAS BEEN REPORTED. THEY HAVE 2 CASES NEXT MORNING. DEVICES ARE AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299742 TVT EXACT RETROPUBIC SYSTEM TVT-CAL-EXACT OTN CALDERA MEDICAL INC. TVTRL 3944788

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown