BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 20427366 · Received October 11, 2024

    Report

    Report Number
    2210968-2024-10689
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    May 11, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. AN ATTEMPT HAS BEEN 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED CITATION: WANG JH, FAN LL, CHEN YH, WANG YJ. ONE AND FIVE-YEAR EFFICACY OF TENSION-FREE VAGINAL TAPE (TVT) ABBREVO AND TVT-OBTURATOR IN THE TREATMENT OF STRESS URINARY INCONTINENCE: A RETROSPECTIVE STUDY. BMC SURG. 2024 MAY 11;24(1):147. DOI: 10.1186/S12893-024-02446-8. PMID: 38734595; PMCID: PMC11088117. HTTPS://PUBMED.NCBI.NLM.NIH.GOV/38734595/.

    Description of Event or Problem · 0

    TITLE: ONE AND FIVE-YEAR EFFICACY OF TENSIONFREE VAGINAL TAPE (TVT) ABBREVO AND TVTOBTURATOR IN THE TREATMENT OF STRESS URINARY INCONTINENCE: A RETROSPECTIVE STUDY. THE STUDY AIMS TO DETERMINE THE SUCCESS RATE OF TVT-O AND TVT-A PROCEDURES, AND IDENTIFY THE SHORT-TERM AND LONG-TERM COMPLICATIONS ASSOCIATED WITH TVT-O AND TVT-A. BETWEEN (B)(6) 2016, A TOTAL OF 96 PATIENTS WITH A MEAN AGE OF 53 YEARS WERE INCLUDED IN THE STUDY. THESE PATIENTS UNDERWENT SURGICAL INTERVENTIONS FOR STRESS URINARY INCONTINENCE (SUI), AND WERE GROUPED ACCORDING TO THE TREATMENT RECEIVED; THE TVT-O GROUP (WHO RECEIVED TVT-O SYSTEM (GYNECARE; ETHICON) WITH 49 PATIENTS, AND THE TVT-A GROUP (WHO RECEIVED TVT-A SYSTEM (GYNECARE; ETHICON) WITH 47 PATIENTS; ALL WERE THEN FOLLOWED UP AT 1 YEAR, AND 5 YEARS AFTER SURGERY. REPORTED COMPLICATIONS WERE: (N=3) LEG PAIN AND (N=4) DYSURIA FOR THE TVT-O GROUP, AND (N=2) LEG PAIN AND (N=3) DYSURIA FOR THE TVT-A GROUP. CONCLUSION: BASED ON THE FINDINGS, TVT-A AND TVT-O PROCEDURES EXHIBITED SIMILARLY HIGH SUCCESS RATES AND LOW FREQUENCIES OF COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301249 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention