BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT EXACT RETROPUBIC SYSTEM

    MDR report key: 22397097 · Received July 3, 2025

    Report

    Report Number
    2210968-2025-07869
    Event Type
    Injury
    Date Received
    July 3, 2025
    Date of Event
    June 20, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031062375
    PMA / PMN Number
    K132054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 RECEIVED: IS THE ADVERSE EVENT SERIOUS? NO DEATH: NO DATE OF DEATH: BLANK 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: NOT RELATED 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: CAUSAL RELATIONSHIP IF THE EVENT IS MARKED AS BEING RELATED TO THE PROCEDURE, INDICATE WHICH PROCEDURE THE EVENT IS RELATED TO: BLANK IF PROCEDURE RELATED AND REPEAT/RETREATMENT IS SELECTED, SPECIFY DATE: BLANK INTERVENTION/TREATMENT: NONE: NO DRUG THERAPY: NO SURGICAL PROCEDURE, THERAPY, OR INTERVENTION: YES SPECIFY: TAPE LOOSENING IN LOCAL ANAESTHESIA NON-SURGICAL PROCEDURE, THERAPY, OR INTERVENTION: NO SPECIFY: BLANK BLOOD TRANSFUSION: NO OTHER: NO IF OTHER SPECIFY: BLANK OUTCOME: RECOVERED/RESOLVED WITHOUT SEQUELAE DID THIS EVENT RESULT IN THE PATIENT¿S DISCONTINUATION OF THE STUDY? NO ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WERE ANY CONCOMITANT PROCEDURES PERFORMED? WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION INCLUDING DATES AND FINDINGS. WAS THE EXPOSED MESH EXCISED? WERE ANY DEFICIENCIES OR ANOMALIES NOTED WITH MESH DEVICE? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? SURGEON¿S NAME? FACILITY NAME? PRODUCT LOT NUMBER? D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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

    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: A2, A3A, A4, B7, E1, E3. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS PROVIDED: THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? URINARY STRESS INCONTINENCE GRADE III. CYSTOCELE GRADE I-II. RECTOCELE GRADE I. WERE ANY CONCOMITANT PROCEDURES PERFORMED? INTRAOPERATIVE CYSTOSCOPY. WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? IMPLANTATION OF A TENSION-FREE RETROPUBIC SLING (TVT EXACT) WITH INTRAOPERATIVE CYSTOSCOPY. WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS? NONE. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? RECTOCELE GRADE I AND CYSTOCELE GRADE I SINCE (B)(6) 2025, NO CONCOMITANT MEDICATION; PATIENT HAS HAD THREE DELIVERIES. DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION INCLUDING DATES AND FINDINGS. BECAUSE OF ELEVATED RESIDUAL URINE OM (B)(6) 2025, THE SLING WAS LOOSENED UNDER LOCAL ANESTHESIA ON (B)(6) 2025. WAS THE EXPOSED MESH EXCISED? MESH WAS NOT EXPOSED. WERE ANY DEFICIENCIES OR ANOMALIES NOTED WITH MESH DEVICE? NONE WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? THE SLING WAS TOO TIGHTLY TENSIONED. WHAT IS THE PATIENT'S CURRENT STATUS? PATIENT IS DOING WELL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2025 AND MESH WAS IMPLANTED. ON (B)(6) 2025, MODERATE RESIDUAL URINE WAS NOTED. THE PATIENT UNDERWENT TAPE LOOSENING IN LOCAL ANAESTHESIA AND THE EVENT WAS RECOVERED/RESOLVED WITHOUT SEQUELAE AS OF (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813854 TVT EXACT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 10705031062375

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention