BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TVT-CAL-EXACT

    MDR report key: 23341300 · Received October 20, 2025

    Report

    Report Number
    3003990090-2025-01645
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    September 29, 2025
    Report Date
    February 9, 2026
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    OTN
    PMA / PMN Number
    K132054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D5, D9, E3, H3, H6, H11. INVESTIGATION RESULTS: THE NEUCHÂTEL TEAM RECEIVED ONE PHOTO FOR EVALUATION OF THE TVT EXACT PRODUCT, PRODUCT CODE TVTRL AND BATCH NUMBER 3945027. AN INVESTIGATION WAS CONDUCTED ON THE PHOTOS RECEIVED AND ON THE BATCH FILE. THE DEVICE RECEIVED HAS BEEN MANIPULATED AND THE BLISTER PACK IS OPEN. THE SEALING TRANSFER IS VISIBLE AND WITHOUT DEFECTS, CONCLUDING THAT THE DEVICES PACKAGING WAS CORRECTLY SEALED AND OPENED AFTERWARDS. DURING THE EVALUATION OF THE PHOTO, THE PRESENCE OF WHITE PARTICLES IS OBSERVED IN THE PRIMARY PACKAGING. NO PARTICLE SIZE MEASUREMENTS CAN BE PERFORMED ON PHOTOS. ACCORDING TO THE EVALUATION, THIS COMPLAINT IS RELATED TO A MANUFACTURING ISSUE. THE DEFECT OBSERVED DURING THE EVALUATION CORRESPONDS TO THE DESCRIPTION OF THE EVENT: (POWER/PLASTIC RESIDUE). THE COMPLAINT IS CONFIRMED AND IS RELATED TO MANUFACTURING (CLASS I DEFECT AS PER WI-EMQD10 REV.25). THE POWDER HAS BEEN CONFIRMED TO BE FROM THE UNDERSIDE OF THE TYVEK ADHESIVE - POWDER IS CREATED DURING TRANSIT WHEN DEVICE/PACKAGING IS CONTACTING UNDERSIDE OF THE TYVEK MATERIAL ALL MATERIALS USED IN THESE DEVICES AND PACKAGING MEET THE BIOCOMPATIBILITY REQUIREMENTS CONTAINED IN ISO 10993-I: "BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING" AND ON FDA GENERAL PROGRAM MEMORANDUM #G95-I: USE OF INTERNATIONAL STANDARD ISO - 10993, "BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING." THE WHITE POWDER HAS BEEN TESTED BY A THIRD-PARTY LABORATORY FOR POTENTIAL CYTOTOXICITY CONCERNS. IT HAS BEEN DETERMINED THAT THE POTENTIAL DEPOSITION OF THESE PARTICLES INTO THE PATIENT WOULD NOT SIGNIFICANTLY INCREASE THE RISK OF TOXICITY. 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 CUSTOMER REPORTED THAT UPON OPENING A TVT (TENSION-FREE VAGINAL TAPE), THEY DISCOVERED A SIGNIFICANT AMOUNT OF POWER AND PLASTIC RESIDUE INSIDE. THE DOCTOR INITIALLY HESITATED TO USE THE FIRST DEVICE UNTIL IT WAS FOUND THAT THE OTHER TVTS PULLED FROM THE SHELF HAD THE SAME ISSUE. ALL OF THEM BELONG TO LOT#: 3945027. THE SURGEON ENDED UP USING TWO OF THE DEVICES AND DISCARDED ONE. AT THE TIME OF SURGERY, THERE WERE NO ISSUES REPORTED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2452349 TVT-CAL-EXACT TVTRL OTN CALDERA MEDICAL INC. 3945027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention