BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT EXACT

    MDR report key: 23871679 · Received December 22, 2025

    Report

    Report Number
    3003990090-2025-01753
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    December 1, 2025
    Report Date
    March 19, 2026
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    OTN
    PMA / PMN Number
    K201686
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE INVESTIGATION IS ONGOING AND THE RESULTS WILL BE REPORTED WHEN AVAILABLE. THE MANUFACTURING NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4, H4, H6, H11. CORRECTION: G1. INVESTIGATION RESULTS: "AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. "A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 5000023 (PRODUCT CODE TVTRL), AND NR-0257578 WAS FOUND FOR THE SUB-ASSEMBLY (PRODUCT CODE P25244, LOT NUMBER 3945013). NR REVIEWER HAS REVIEWED THE NR FILE AND HAS CONCLUDED, BASED ON THE INFORMATION AVAILABLE IN THE NR FILE, THAT NR-0257578 IS NOT RELATED TO THE REPORTED COMPLAINT CONDITION OR IDENTIFIED MALFUNCTION. EXPIRATION DATE: 31. JUL. 2026 MANUFACTURING DATE: 28.AUG.2025" AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION, THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE ACTION IS REQUIRED AT THIS TIME. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE." THE INTERNAL COMPLAINT MANUFACTURING NUMBER IS (B)(4).

    Description of Event or Problem · 0

    TVT SLING REMOVED DUE TO URINARY RETENTION DETAILED DESCRIPTION OF THE EVENT CREATED UNCOMPLICATED TVT SLING FROM GYNECARE TVT EXACT LOT NO: 5000023 JOHNSON & JOHNSON. SUBSEQUENT URINARY RETENTION AND LACK OF SUFFICIENT BLADDER EMPTYING. TRAINED IN RIK, BUT STILL PROBLEMS AND THEREFORE SOLUTION OF THE SLING AT (REMOVED) UROGYNECOLOGY DEPARTMENT ON (B)(6) 2025. CONTINUED NOT EMPTYING SUFFICIENT OF THE BLADDER AND THEREFORE REMOVAL OF THE SLING AT (REMOVED) UROGYNECOLOGY DEPARTMENT ON (B)(6) 2025. UNCOMPLICATED POST-OPERATIVE COURSE. WHEN REVIEWING THE FLOW BEFORE SURGERY, THERE IS A TENDENCY TO BLADDER URINATION, WHICH CAN EXPLAIN THE PROBLEMS WITH BLADDER EMPTYING AFTER THE SLING INSTALLATION. CONSEQUENCE OF THE INCIDENT *NECESSITATED MEDICAL OR SURGICAL TREATMENT, INCORRECT OR DELAYED DIAGNOSIS OR TREATMENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11229 GYNECARE TVT EXACT TVT-CAL-EXACT OTN CALDERA MEDICAL INC. TVTRL 5000023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention