BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TVT EXACT RETROPUBIC SYSTEM

    MDR report key: 23404890 · Received October 28, 2025

    Report

    Report Number
    3003990090-2025-01685
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 7, 2025
    Report Date
    January 28, 2026
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    OTN
    PMA / PMN Number
    K132054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D5, E3, H6, H11. INVESTIGATION RESULTS: NEUCHATEL TEAM RECEIVED FOR EVALUATION 15 PRODUCTS OF GYNECARE EXACT PRODUCT CODE TVTRL AND LOT NUMBER 3945027. AN INVESTIGATION WAS PERFORMED ON RECEIVED PRODUCT AND ON THE BATCH RECORD FILE. A DEVICE RECEIVED HAS BEEN MANIPULATED AND ONLY TROCAR. ALL OF THE FOLLOWING COMPONENTS ARE MISSING: BOX, IFU, BLISTER, LID, WORKSTATION, RETAINER, NEEDLES, AND MESH. ON THE TIP OF THE TROCAR, THE PRESENCE OF GLUE WITH FIBERS IS OBSERVED. A DEVICE RECEIVED HAS BEEN MANIPULATED AND THE BLISTER PACK IS OPEN. THE FOLLOWING COMPONENTS ARE MISSING BOX, IFU, AND WORKSTATION. THE SEALING TRANSFER IS VISIBLE AND WITHOUT DEFECTS, CONCLUDING THAT THE DEVICES PACKAGING WAS CORRECTLY SEALED AND OPENED AFTERWARDS. ON THIRTEEN DEVICES RECEIVED, NO DAMAGE OR FOREIGN MATTER WAS FOUND ON THE BLISTER PACK. THE SEAL IS CLEARLY VISIBLE AND COMPLIANT. THE DEVICES RECEIVED ARE IN ITS PRIMARY AND SECONDARY PACKAGING, INCLUDING THE IFU. THE IDENTIFICATION LABELS ON THE LID AND BLISTER CORRESPOND TO THE BATCH. MULTIPLE PACKAGES RECEIVED HAD SLIGHT DAMAGE TO THE BOX. THE IDENTIFICATION LABELS TO THE BOX CORRESPOND TO THE BATCH. 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: (WHITE POWDER/ DUST WITHIN THE STERILE 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 C25-2882

    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 29 TVTRL DEVICES (LOT #3945027, EXPIRING ON 05/31/2026) WERE FOUND TO BE UNUSED DUE TO WHITE FRAGMENTS IN THE PACKAGING. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2217378 TVT EXACT RETROPUBIC SYSTEM TVT-CAL-EXACT OTN CALDERA MEDICAL INC. TVTRL 3945027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown