BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT

    MDR report key: 23439465 · Received October 31, 2025

    Report

    Report Number
    3003990090-2025-01697
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    February 27, 2023
    Report Date
    December 17, 2025
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    OTN
    UDI-DI
    10705031062375
    PMA / PMN Number
    K201686
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION COULD NOT BE PERFORMED AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED EVENT WAS NOT IDENTIFIED. WITHOUT A LOT NUMBER, A REVIEW OF DEVICE HISTORY RECORDS OR PRODUCTION-SPECIFIC DATA COULD NOT BE CONDUCTED, THEREBY LIMITING THE ABILITY TO PERFORM A THOROUGH ROOT CAUSE INVESTIGATION. A REVIEW OF GENERAL MANUFACTURING RECORDS INDICATES THAT ALL PRODUCTS RELEASED DURING THE RELEVANT TIMEFRAME WERE MANUFACTURED IN ACCORDANCE WITH APPROVED PROCEDURES AND MET ESTABLISHED SPECIFICATIONS DURING THE MANUFACTURING AND QUALITY RELEASE PROCESS. BASED ON THE INFORMATION AVAILABLE, NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS COMPLAINT WILL BE DOCUMENTED AND MONITORED THROUGH POST-MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS NECESSARY. THE MANUFACTURING NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4, D5, H4, H6, H11. CORRECTION: G2. 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 LOT NUMBER 3942794 (PRODUCT CODE TVTRL), AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. EXPIRATION DATE: 30.SEP.2023 MANUFACTURING DATE: 19.OCT.2022" 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 MANUFACTURING NUMBER IS (B)(4).

    Description of Event or Problem · 0

    CLINICAL TRIAL PATIENT (B)(6) EXPERIENCED VOIDING DYSFUNCTION CHARACTERIZED BY AN ABNORMAL STREAM. RELATIONSHIP TO STUDY DEVICE: POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494787 TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT TVT-CAL-EXACT OTN CALDERA MEDICAL INC. TVTRL 3942794 10705031062375

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention