BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TVT EXACT RETROPUBIC SYSTEM

    MDR report key: 23404605 · Received October 28, 2025

    Report

    Report Number
    3003990090-2025-01684
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 6, 2025
    Report Date
    November 24, 2025
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    OTN
    PMA / PMN Number
    K132054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE DHR REVIEW WAS CONDUCTED, AND THE NEUCHÂTEL TEAM RECEIVED A GYNECARE EXACT PRODUCT FOR EVALUATION, SPECIFICALLY PRODUCT CODE TVTRL AND LOT NUMBER 3945027. AN INVESTIGATION WAS CARRIED OUT ON THE RECEIVED PRODUCT AND THE BATCH RECORD FILE. THE PRODUCT WAS WELL-PACKAGED, AND ACCORDING TO THE PRODUCT IDENTIFICATION, NO DECONTAMINATION WAS REQUIRED. THE DEVICE WAS RECEIVED IN ITS PRIMARY AND SECONDARY PACKAGING, WHICH INCLUDED THE INSTRUCTIONS FOR USE (IFU). ALTHOUGH THE LID OF THE BLISTER PACK HAD A SLIGHT CRUMPLE NEAR THE OPENING, NO FOREIGN OBJECTS WERE FOUND ON THE BLISTER PACK ITSELF. THE IDENTIFICATION LABELS ON BOTH THE LID AND THE BLISTER PACK MATCHED THE BATCH INFORMATION. WHILE THE BLISTER PACK APPEARED TO HAVE BEEN MANIPULATED AND OPENED, THE VISIBLE SEALING TRANSFER SHOWED NO DEFECTS, INDICATING THAT THE PACKAGING WAS CORRECTLY SEALED BEFORE OPENING. DURING THE PRODUCT EVALUATION, THE MANUFACTURING TEAM OBSERVED WHITE PARTICLES IN THE PRIMARY PACKAGING. PARTICLE SIZES WERE MEASURED USING A TAPPI CHART (# (B)(4)) AND A CALIBRATED RULER (# (B)(4)). ALL MEASURED PARTICLES WERE LESS THAN 0.4 MM² OR 3 MM IN LENGTH AND WERE NOT ATTRIBUTABLE TO THE PRODUCT ITSELF, SPECIFICALLY THE MESH OR ANY WHITE PARTICLES GENERATED DURING MANUFACTURING. NO OTHER DEFECTS WERE IDENTIFIED DURING THE EVALUATION. THE EVALUATION CONCLUDED THAT THIS COMPLAINT WAS RELATED TO A MANUFACTURING ISSUE. THE DEFECT OBSERVED ALIGNS WITH THE REPORTED INCIDENT OF WHITE FRAGMENTS FOUND INSIDE THE PACKAGING. THIS COMPLAINT HAS BEEN CONFIRMED AS A RESULT OF A MANUFACTURING ERROR, CLASSIFIED AS A CLASS I DEFECT ACCORDING TO WI-EMQD10 REV.25. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN HAS BEEN INITIATED TO INVESTIGATE AND IMPLEMENT CORRECTIVE MEASURES, WHICH ARE CURRENTLY UNDERWAY TO ADDRESS AND MITIGATE THE OCCURRENCE OF WHITE PARTICULATES. THIS ISSUE HAS BEEN ESCALATED AND DOCUMENTED. FURTHERMORE, WE WILL CONTINUE TO MONITOR COMPLAINT INFORMATION FOR POTENTIAL SAFETY SIGNALS THROUGH COMPLAINT TRENDING AS PART OF OUR POST-MARKET SURVEILLANCE. 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

    A HEALTHCARE PROVIDER REPORTED THAT THREE TVTRL DEVICES (LOT # 3945027, EXPIRING ON 05/31/2026) WERE OPENED ON 10/06/2025 AND FOUND TO BE UNUSED DUE TO WHITE FRAGMENTS DISCOVERED INSIDE THE PACKAGING. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552166 TVT EXACT RETROPUBIC SYSTEM TVT-CAL-EXACT OTN CALDERA MEDICAL INC. TVTRL 3945027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown