BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TVT EXACT RETROPUBIC SYSTEM

    MDR report key: 23444341 · Received October 31, 2025

    Report

    Report Number
    3003990090-2025-01703
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 23, 2025
    Report Date
    February 19, 2026
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    OTN
    PMA / PMN Number
    K132054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D5, E3, H6, H11 INVESTIGATION RESULTS: DHR REVIEW ------------------------------------------------------------------------------------------------------------------------------------ NEUCHATEL TEAM RECEIVED FOR EVALUATION 11 PRODUCTS OF GYNECARE EXACT. TEN PRODUCTS CODE TVTRL AND LOT NUMBER 3945035 AND ONE PRODUCT CODE TVTRL AND LOT NUMBER 3944989. AN INVESTIGATION WAS PERFORMED ON RECEIVED PRODUCTS AND ON THE BATCH RECORDS FILES. TEN DEVICES RECEIVED ARE IN ITS PRIMARY AND SECONDARY PACKAGING, INCLUDING THE IFU. A PRODUCT WAS RECEIVED MISSING THE IFU AND BOX. TWO DEVICES 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. THE LIDS ARE SLIGHTLY BENT. THE IDENTIFICATION LABELS ON THE LID AND BLISTER CORRESPOND TO THE BATCH. ON NINE DEVICES RECEIVED, NO DAMAGE OR FOREIGN MATTER WAS FOUND ON THE BLISTER PACK. THE SEAL IS CLEARLY VISIBLE AND COMPLIANT. THE IDENTIFICATION LABELS ON THE LID AND BLISTER CORRESPOND TO THE BATCH. TWO PACKAGES RECEIVED HAD SLIGHT DAMAGE TO THE BOX. THREE BOXES HAVE LABELS AFFIXED THAT ARE NOT PART OF THE MANUFACTURING PROCESS IN NEUCHÂTEL. DURING THE PRODUCTS EVALUATION, THE NEUCHÂTEL TEAM OBSERVED WHITE PARTICLES IN THE PRIMARY PACKAGING. A MEASUREMENT OF PARTICLES SIZES HAS BEEN PERFORMED WITH A TAPPI CHART #NE1685 AND A CALIBRATED RULER #G12463, AS FOLLOW: ALL PARTICLES MEASURED WERE LESS THAN 0.4 MM² OR 3 MM IN LENGTH BUT NOT ATTRIBUTABLE TO THE PRODUCT (MESH OR WHITE PARTICLE FROM THE MESH GENERATED DURING THE MANUFACTURING). NO OTHER DEFECTS WERE FOUND DURING THE PRODUCT EVALUATION. 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: (A WHITE PARTICULATE SUBSTANCE INSIDE THE SEALED PACKAGING). 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 C25-2902

    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 A HEALTHCARE PROFESSIONAL THAT SEVERAL OF THEIR FACILITIES RECENTLY RECEIVED SHIPMENTS OF THE GYNECARE TVT EXACT CONTINENCE SYSTEM. DURING A RECENT PROCEDURE, ONE OF THE DEVICES WAS OPENED AND FOUND TO CONTAIN A WHITE PARTICULATE SUBSTANCE INSIDE THE SEALED PACKAGING AND ON THE DEVICE ITSELF. ADDITIONAL UNITS WERE INSPECTED AND FOUND TO HAVE A SIMILAR ISSUE. NO PATIENT CONSEQUENCES ARE REPORTED. DEVICE AVAILABILITY IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1589113 TVT EXACT RETROPUBIC SYSTEM TVT-CAL-EXACT OTN CALDERA MEDICAL INC. TVTRL 3945035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown