BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TVT-CAL-EXACT

    MDR report key: 23341663 · Received October 20, 2025

    Report

    Report Number
    3003990090-2025-01646
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    September 30, 2025
    Report Date
    December 10, 2025
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    OTN
    PMA / PMN Number
    K132054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4 ,D8, D9 H3, D6, H3, H4, H6, H11. INVESTIGATION RESULTS: DHR REVIEW: THE INVESTIGATION TEAM RECEIVED A PRODUCT FROM GYNECARE, SPECIFICALLY THE EXACT PRODUCT CODE TVTRL AND LOT NUMBER 3945027, FOR EVALUATION. AN INVESTIGATION WAS CONDUCTED ON THE RECEIVED PRODUCT AS WELL AS THE BATCH RECORD FILE. THE PRODUCT WAS WELL-PACKAGED, AND ACCORDING TO THE PRODUCT IDENTIFICATION, "NO DECONTAMINATION" WAS REQUIRED. FOR DETAILS ON THE SHIPMENT MANIFEST, PLEASE REFER TO THE ACCOMPANYING DOCUMENT. THE DEVICE WAS RECEIVED IN BOTH ITS PRIMARY AND SECONDARY PACKAGING, WHICH INCLUDED THE INSTRUCTIONS FOR USE (IFU). NO DAMAGE OR FOREIGN MATTER WAS OBSERVED ON THE BLISTER PACK. THE SEAL WAS CLEARLY VISIBLE AND COMPLIANT, WITH THE IDENTIFICATION LABELS ON THE LID AND BLISTER MATCHING THE BATCH. HOWEVER, THE OUTER BOX SHOWED SLIGHT DAMAGE, AND A LABEL THAT IS NOT PART OF THE MANUFACTURING PROCESS WAS AFFIXED TO IT. DURING THE PRODUCT EVALUATION, THE TEAM NOTED THE PRESENCE OF WHITE PARTICLES IN THE PRIMARY PACKAGING. MEASUREMENTS OF THE PARTICLE SIZES WERE TAKEN USING A TAPPI CHART #NE1685, WITH ALL PARTICLES MEASURING LESS THAN 0.4 MM² OR 3 MM IN LENGTH. THESE PARTICLES WERE NOT ATTRIBUTABLE TO THE PRODUCT; THEY WERE IDENTIFIED AS MESH OR WHITE PARTICLES GENERATED DURING THE MANUFACTURING PROCESS. NO OTHER DEFECTS WERE FOUND DURING THE EVALUATION. A MANUFACTURING RECORD EVALUATION WAS CONDUCTED, FOR FINISHED DEVICE LOT NUMBER 3945027 (PRODUCT CODE TVTRL). THE NONCONFORMANCE REPORT (NR) NR-0254780 WAS FOUND. THE NR REVIEWER REVIEWED THIS FILE AND CONCLUDED THAT NR-0254780 WAS NOT RELATED TO THE REPORTED COMPLAINT CONDITION OR THE IDENTIFIED MALFUNCTION. ACCORDING TO THE EVALUATION, THIS COMPLAINT PERTAINS TO A MANUFACTURING ISSUE. THE DEFECT OBSERVED DURING THE ASSESSMENT MATCHES THE EVENT DESCRIPTION: THE PRODUCT WAS CONTAMINATED WITH WHITE DUST PARTICLES INSIDE. THE COMPLAINT HAS BEEN CONFIRMED AND CLASSIFIED AS A MANUFACTURING DEFECT. CAPA-014703 WAS INITIATED TO INVESTIGATE THE ROOT CAUSE AND TO IMPLEMENT CORRECTIVE ACTIONS. THE PRODUCT INVESTIGATION REPORT (PI-17598524762101226) IS CONFIDENTIAL AND INTENDED FOR INTERNAL USE ONLY. IT WAS GENERATED ON DECEMBER 3, 2025, AT 9:14:11 AM (AMERICA/NEW_YORK) AND DOCUMENTS THE ONGOING PROCESS TO ADDRESS AND IMPROVE THE OCCURRENCE OF WHITE PARTICULATE CONTAMINATION. THIS ISSUE HAS BEEN ESCALATED PER PR551-002 AND RECORDED WITHIN ETQ # PIA-0000704. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS ALSO PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 3945025 (PRODUCT CODE TVTRL), AND NR-0254780 WAS AGAIN FOUND. THE NR REVIEWER CONFIRMED THAT NR-0254780 WAS NOT RELATED TO THE REPORTED COMPLAINT OR IDENTIFIED MALFUNCTION. EXPIRATION DATE: MAY 31, 2026. MANUFACTURING DATE: JUNE 4, 2025. THE MANUFACTURING NUMBER IS C25-2867.

    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 HAS COME TO MY ATTENTION THAT THE TVT EXACT WE HAVE IN STOCK APPEARS TO BE CONTAMINATED WITH A WHITE DUST OR SUBSTANCE, WHICH WE SUSPECT MAY BE PART OF THE WHITE RUBBER TIP. AS A RESULT, THE SURGEON IS USING AN ALTERNATIVE PRODUCT DUE TO THIS ISSUE. ALL THE ITEMS WE HAVE ON HAND ARE FROM THE SAME LOT: 3945027. WE WOULD LIKE TO ARRANGE FOR THEM TO BE SWAPPED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999867 TVT-CAL-EXACT TVTRL OTN CALDERA MEDICAL INC. 3945027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown