BEUDAMED
    FDA Adverse Event Injury Summary report: N

    "TVT-CAL-ABDOMINAL

    MDR report key: 23297406 · Received October 15, 2025

    Report

    Report Number
    3003990090-2025-01638
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 16, 2025
    Report Date
    November 19, 2025
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    OTN
    UDI-DI
    10705031062283
    PMA / PMN Number
    K173162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION COULD NOT BE PERFORMED AS THE DEVICE IS NOT RETURNED. BASED ON THE LIMITED INFORMATION PROVIDED, THE REPORTED PRODUCT COMPLAINT COULD NOT BE CONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A3, B5, E3, G4, H5, H6, H11. CORRECTION: B5, E1, G2. INVESTIGATION RESULTS: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. THE MANUFACTURING NUMBER IS C25-2856.

    Description of Event or Problem · 0

    "WCQ RECEIVED AN E-MAIL FROM THE ETHICON RISK MANAGER TEAM STATING THE FOLLOWING: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2008 AND TVT WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6)2008 AND TVT WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ANUNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020056 "TVT-CAL-ABDOMINAL TVT W/ABDOMINAL GUIDES OTN CALDERA MEDICAL INC. 810041A 3182097 10705031062283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other