BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT EXACT RETROPUBIC SYSTEM

    MDR report key: 22036563 · Received May 16, 2025

    Report

    Report Number
    2210968-2025-05446
    Event Type
    Injury
    Date Received
    May 16, 2025
    Date of Event
    March 14, 2025
    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
    PHYSICIAN
    Health Professional
    Yes

    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: H6. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    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 DETAILS: LIFE-THREATENING ILLNESS OR INJURY: NO PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION: NO REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION: NO ADMISSION DATE: BLANK DISCHARGE DATE: BLANK RESULTED IN MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION: NO LED TO FETAL DISTRESS, FETAL DEATH OR A CONGENITAL ABNORMALITY OR BIRTH DEFECT: NO RELATIONSHIP TO STUDY DEVICE: POSSIBLE IF EVENT IS SERIOUS AND DEVICE RELATED (UNLIKELY, POSSIBLE, PROBABLE, OR CAUSAL RELATIONSHIP), ACCORDING TO THE PROTOCOL AND INSTRUCTIONS FOR USE, IN THE OPINION OF THE INVESTIGATOR, IS THE ADVERSE EVENT EXPECTED/ANTICIPATED? N/A RELATIONSHIP TO PRIMARY STUDY PROCEDURE: POSSIBLE IF THE EVENT IS MARKED AS BEING RELATED TO THE PROCEDURE, INDICATE WHICH PROCEDURE THE EVENT IS RELATED TO: INDEX IF PROCEDURE RELATED AND REPEAT/RETREATMENT IS SELECTED, SPECIFY DATE: BLANK INTERVENTION/TREATMENT: NONE: NO DRUG THERAPY: YES SURGICAL PROCEDURE, THERAPY, OR INTERVENTION: NO SPECIFY: BLANK NON-SURGICAL PROCEDURE, THERAPY, OR INTERVENTION: NO SPECIFY: BLANK BLOOD TRANSFUSION: NO OTHER: NO IF OTHER SPECIFY: BLANK OUTCOME: NOT RECOVERED/NOT RESOLVED DID THIS EVENT RESULT IN THE PATIENT¿S DISCONTINUATION OF THE STUDY? NO. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS PROVIDED: WERE ANY CONCOMITANT PROCEDURES PERFORMED? ALL PROCEDURE(S) DONE AT TIME OF SLING PLACEMENT: VAGINAL HYSTERECTOMY UTEROSACRAL LIGAMENT SUSPENSION MESH SLING CYSTOSCOPY ANTERIOR AND POSTERIOR REPAIR AND ENTEROCELE REPAIR EXAM UNDER ANESTHESIA HAS THE INCONTINENCE CHANGED FROM PRE-SURGERY CONDITION? (WORSE, BETTER, OR RETURNED TO THE SAME) PER PATIENT REPORT, INCONTINENCE HAS GOTTEN WORSE. PLEASE DESCRIBE ANY MEDICAL INTERVENTION REQUIRED TO TREAT THE INCONTINENCE INCLUDING MEDICATION NAME AND RESULTS. MYRBETRIQ ¿ MIRABEGRON 50 MG ER TABLET 1 TABLET BY MOUTH ONCE DAILY FOR 90 DAYS OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? PATIENT HAS A SURGICAL HX OF LAPROSCOPIC GASTRIC BYPASS - POST SURGERY REQUIRES INCREASED FLUID INTAKE WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? LIKELY EXACERBATED BY REQUIREMENT TO DRINK 64 OZ + OF WATER DAILY DUE TO BARIATRIC SURGERY. WHAT IS THE PATIENT'S CURRENT STATUS? PATIENT IS ON-STUDY, ACTIVELY TAKING THE ABOVE PRESCRIBED MEDICATION AND TRYING TO REDUCE DAILY FLUID INTAKE. PATIENT HAS COMPLETED A BLADDER DIARY THAT WAS REVIEWED BY THE PROVIDER. PRODUCT CODE AND LOT NUMBER? SYSTEM, RETROPUBIC TVT EXACT SM-NDL TVTRL LOT #: 3944892 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2025 AND MESH WAS IMPLANTED. MILD URGE URINARY INCONTINENCE WAS NOTED ON (B)(6) 2025. DRUG THERAPY WAS PROVIDED AND THE EVENT HAS NOT RECOVERED/NOT RESOLVED. THIS 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
    1896248 TVT EXACT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3944892 10705031062375

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention