BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    "TVT-CAL-EXACT

    MDR report key: 23290292 · Received October 15, 2025

    Report

    Report Number
    3003990090-2025-01627
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 17, 2025
    Report Date
    January 13, 2026
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    OTN
    PMA / PMN Number
    K201686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9 - H3. THE MANUFACTURING NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D5, E3, H6, H11. INVESTIGATION RESULTS: NEUCHATEL TEAM RECEIVED FOR EVALUATION ONE PRODUCT OF GYNECARE EXACT PRODUCT CODE TVTRL AND LOT NUMBER 3944972. AN INVESTIGATION WAS PERFORMED ON RECEIVED PRODUCT AND ON THE BATCH RECORD FILE. THE PRODUCT WAS WELL PACKAGED AND ACCORDING TO THE PRODUCT IDENTIFICATION NO DECONTAMINATION WAS REQUIRED. FOR THE SHIPMENT MANIFEST, PLEASE SEE THE DOCUMENT (B)(4)_SHIPMENT MANIFEST IN THE NOTES &ATTACHMENTS SECTION). THE DEVICE RECEIVED IS IN ITS PRIMARY AND SECONDARY PACKAGING, INCLUDING THE IFU. NO DAMAGE WAS FOUND ON THE BLISTER PACK. THE BLISTER PACK WAS OPENED AND THE LID WAS SECURED TO THE BLISTER PACK WITH CLEAR ADHESIVE TAPE. SEALING MARKS ARE VISIBLE ON THE BLISTER PACK, INDICATING THAT THE SEAL WAS INTACT. THE IDENTIFICATION LABELS ON THE LID AND BLISTER PACK CORRESPOND TO THE BATCH. THE PACKAGE RECEIVED WAS DAMAGED AND HAD TAPE STUCK TO THE OPENING, WHERE THE CARDBOARD WAS DAMAGED. THE TAPE IS ALSO STUCK TO THE BOTTOM OF THE BOX. THIS TAPE IS NOT PART OF THE NEUCHÂTEL MANUFACTURING PROCESS. MULTIPLE LABELS ARE AFFIXED TO THE BOX THAT ARE NOT PART OF THE MANUFACTURING PROCESS IN NEUCHÂTEL. DURING THE PRODUCT 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 FOLLOWS: ALL PARTICLES MEASURED WERE LESS THAN 0.4 MM 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED BY ON OCTOBRE 28, 2025 AND THE BATCH MET ALL FINISHED GOOD RELEASE CRITERIA FOR LOT 3944972 AND PRODUCT CODE TVTRL. NO NONCONFORMANCE WAS IDENTIFIED. 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: (FOREIGN MATTER. WHITE DUST ADHERING TO THE PRODUCT). THE COMPLAINT IS CONFIRMED AND IS RELATED TO MANUFACTURING (CLASS I DEFECT AS PER WI-EMQD10 REV.25). CAPA-014703 INITIATED FOR INVESTIGATION AND ROOT CAUSE CORRECTIVE ACTION IMPLEMENTATION IN PROCESS OF BEING OPENED TO CAPTURE INVESTIGATION AND IMPROVE WHITE PARTICULATE OCCURRENCE. THIS ISSUE HAS BEEN ESCALATED AS PER (B)(4) AND RECORDED WITHIN ETQ # PIA-0000704. 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."

    Description of Event or Problem · 0

    "FOREIGN MATTER. THE DOCTOR OPENED THE STERILE PACKAGING AND FOUND WHITE DUST ADHERING TO THE PRODUCT. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2338692 "TVT-CAL-EXACT "TVT EXACT RETROPUBIC SYSTEM" OTN CALDERA MEDICAL INC. TVTRL 3944972

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other