BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT

    MDR report key: 21875720 · Received April 21, 2025

    Report

    Report Number
    2210968-2025-04077
    Event Type
    Injury
    Date Received
    April 21, 2025
    Date of Event
    January 1, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K132054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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: H6 PLEASE SEE FULL ARTICLE ATTACHED.

    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. 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: INT UROGYNECOL J. 2025 MAR 29. DOI: 10.1007/S00192-025-06119-9. EPUB AHEAD OF PRINT. PMID: 40156655.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: THE AIM OF THIS STUDY IS TO INVESTIGATE PATIENT CHOICE, DEMOGRAPHICS, RE-TREATMENTS, AND COMPLICATIONS FOR THESE PROCEDURES. PATIENT DEMOGRAPHICS WERE COLLECTED FROM THE HOSPITAL REGISTRY FOR WOMEN WITH PRIMARY SUI (STRESS URINARY INCONTINENCE) TREATED WITH TVT (TENSION-FREE VAGINAL TAPE) OR PAHG (POLYACRYLAMIDE HYDROGEL) INCLUDING PATIENT AGE, BODY MASS INDEX, SMOKING STATUS, OBSTETRIC HISTORY, AND PRIOR PELVIC SURGERIES. AMONG 391 PRIMARY PROCEDURES 55% (N = 217) OF WOMEN CHOSE THE TVT AND 45% (N = 174) THE PAHG TREATMENT, WITH SIMILAR PATIENT DEMOGRAPHICS. REPORTED COMPLICATION ARE: COMPLICATIONS OCCURRED IN 14.3% AFTER TVT. IN CONCLUSION, SIMILAR CLINICAL PROFILES IN BOTH TVT AND PAHG GROUPS SUGGEST NO SPECIFIC DEMOGRAPHIC FACTORS PREDICT DECISION MAKING. AFTER A 2-YEAR FOLLOW-UP, THE OVERALL COMPLICATION RATES WERE SIMILAR, WITH PAHG ASSOCIATED WITH A HIGHER LIKELIHOOD OF REQUIRING RE-TREATMENT, WHEREAS TVT CARRIED A GREATER RISK OF SEVERE COMPLICATIONS. THE RETREATMENT RATES WERE LOWER THAN PREVIOUSLY REPORTED, INDICATING THAT ACTUAL PATIENTS ARE FAIRLY SATISFIED WITH THEIR PRIMARY CHOICE. NO CONTACT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015135 TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention