BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT EXACT RETROPUBIC SYSTEM

    MDR report key: 21379515 · Received February 13, 2025

    Report

    Report Number
    2210968-2025-01660
    Event Type
    Injury
    Date Received
    February 13, 2025
    Date of Event
    January 5, 2023
    Report Date
    June 8, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031062375
    PMA / PMN Number
    K132054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS PROVIDED: NAME OF INDEX SURGICAL PROCEDURE? TVT MESH SLING ¿ RETROPUBIC TVT SLING. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? STRESS INCONTINENCE IN FEMALE. WERE ANY CONCOMITANT PROCEDURES PERFORMED? CYSTOSCOPY. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? ABNORMAL PAP SMEAR, HPV INFECTION, COLPOSCOPY AND MIXED INCONTINENCE (URGE). WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? NONE. DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? CEFAZOLIN IN DEXTROSE IVPB 2 G/50 ML (INTRAOPERATIVE), NITROFURANTOIN MONOHYD/M-CRYST 100 MG AND 1 100 MG CAPSULE BY MOUTH ONCE DAILY FOR 5 DAYS WHILE PERFORMING SELF CATH (POST OPERATION). WERE CULTURES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS. + ECOLI (B)(6) 2024 AND + ECOLI (B)(6) 2023. PLEASE DESCRIBE ANY MEDICAL INTERVENTION PERFORMED INCLUDING MEDICATION NAME AND RESULTS. START LOCALLY APPLIED ESTROGEN CREAM, APPLIED EVERY OTHER DAY AROUND THE URETHRA AND VAGINAL OPENING. (ESTRACE CREAM). DUE TO +ECOLI CULTURE, PRESCRIBED BACTRIM 160 MG TABLETS (1 TAB TWO TIMES DAILY FOR 7 DAYS) RECOMMEND OVER-THE-COUNTER VAGINAL AND ORAL PROBIOTICS, SPECIFICALLY FROM SEED. FOLLOW-UP IN 1 YEAR OR SOONER IF UTIS PERSIST OR WORSEN. TELEHEALTH VISITS ARE AN OPTION. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? RECURRENT UTIS WITH RECENT ODOR TO URINE. STARTED AFTER SLING SURGERY BUT ALSO HAD ONE PRIOR TO SLING AND COULD HAVE POSSIBLE MICROBIOME DISRUPTION DUE TO PERIMENOPAUSAL HORMONAL CHANGES. WHAT IS THE PATIENT'S CURRENT STATUS? ON-STUDY, STABLE. TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2022 AND MESH WAS IMPLANTED FOR STRESS INCONTINENCE. ON (B)(6) 2023, MILD RECURRENT URINARY TRACT INFECTION WAS NOTED. THE PATIENT STARTED LOCALLY APPLIED ESTROGEN CREAM, APPLIED EVERY OTHER DAY AROUND THE URETHRA AND VAGINAL OPENING. DUE TO +ECOLI CULTURE, PRESCRIBED BACTRIM 160 MG TABLETS (1 TAB TWO TIMES DAILY FOR 7 DAYS). RECOMMENDED OVER-THE-COUNTER VAGINAL AND ORAL PROBIOTICS, SPECIFICALLY FROM SEED. FOLLOW-UP IN 1 YEAR OR SOONER IF UTIS PERSIST OR WORSEN. THIS EVENT WAS REPORTED AS POSSIBLY RELATED TO THE STUDY DEVICE AND STUDY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125834 TVT EXACT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3941519 10705031062375

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention