BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE UNKNOWN

    MDR report key: 24208457 · Received January 29, 2026

    Report

    Report Number
    2210968-2026-01039
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    February 1, 2004
    Report Date
    January 29, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. 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. 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? 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: AM J OBSTET GYNECOL. 2004 FEB;190(2):324-31. HTTPS://DOI.ORG/10.1016/J.AJOG.2003.07.029 PMID: 14981369.

    Description of Event or Problem · 0

    TITLE: UK AND IRELAND TVT TRIAL GROUP. A PROSPECTIVE MULTICENTER RANDOMIZED TRIAL OF TENSION-FREE VAGINAL TAPE AND COLPOSUSPENSION FOR PRIMARY URODYNAMIC STRESS INCONTINENCE: TWO-YEAR FOLLOW-UP. THIS STUDY WAS UNDERTAKEN TO COMPARE TENSION-FREE VAGINAL TAPE (TVT) WITH COLPOSUSPENSION IN A PROSPECTIVE RANDOMIZED MANNER, USING VALIDATED OUTCOME MEASURES. WOMEN WITH URODYNAMIC STRESS INCONTINENCE UNRESPONSIVE TO PELVIC FLOOR MUSCLE EXERCISE, WHO HAD COMPLETED THEIR FAMILY, WERE INVITED TO PARTICIPATE. FOURTEEN CENTERS IN THE UNITED KINGDOM AND IRELAND RECRUITED PATIENTS TO THE STUDY. THREE HUNDRED FORTY-FOUR WOMEN WERE RANDOMLY SELECTED (175 TO TVT AND 169 TO COLPOSUSPENSION). THE TVT PROCEDURE WAS PERFORMED UNDER LOCAL ANESTHESIA AND SEDATION, USING THE GYNECARE TVT DEVICE (GYNECARE, ETHICON INC, SOMERVILLE, NJ). COLPOSUSPENSION WAS PERFORMED ACCORDING TO THE STANDARD TECHNIQUE USED BY UNITS AT THE TIME; PRELIMINARY PROTOCOL DISCUSSIONS BETWEEN COLLABORATING SURGEONS INDICATED REASONABLE UNIFORMITY, ALL UNITS USING EITHER TWO OR THREE SUTURES OF EITHER POLYDIOXANONE (PDS, ETHICON INC) OR BRAIDED POLYESTER (ETHIBOND, ETHICON, INC) TO SUPPORT PARAVAGINAL FASCIA FROM THE ILEOPECTINEAL LIGAMENT ON EACH SIDE. MEAN FOLLOW-UP PERIOD IS 2 YEARS. REPORTED COMPLICATIONS INCLUDE: PDS OR ETHIBOND (ETHICON): (N=47) CYSTOCELE/CYSTOURETHROCELE. TREATMENT: NOT REPORTED IN THE ARTICLE. (N=78) VAULT OR CERVICAL PROLAPSE/ENTEROCOELE. TREATMENT: NOT REPORTED IN THE ARTICLE. (N=59) RECTOCELE. TREATMENT: NOT REPORTED IN THE ARTICLE. (N=5) URODYNAMIC STRESS INCONTINENCE. TREATMENT: 3 PATIENTS UNDERWENT TVT WHILE 2 PATIENTS WAS UNSPECIFIED (SURGERY OUTSIDE TRIAL CENTERS). (N=1) PROLAPSE. TREATMENT: VAGINAL HYSTERECTOMY. (N=3) PROLAPSE. TREATMENT: VAGINAL HYSTERECTOMY AND POSTERIOR COLPORRAPHY. ONE PATIENT ALSO UNDERWENT TVT PROCEDURE.. (N=3) PROLAPSE. TREATMENT: POSTERIOR COLPORRAPHY AND ONE PATIENT ALSO HAD AN ANAL SPHINCTER REPAIR. (N=3) RECURRENT URINARY TRACT INFECTION. TREATMENT: NOT REPORTED IN THE ARTICLE. (N=4) VOIDING DISORDER. TREATMENT: REQUIRING INTERMITTENT SELF-CATHETERIZATION. IN CONCLUSION, THE TVT PROCEDURE APPEARS TO BE AS EFFECTIVE AS COLPOSUSPENSION FOR THE TREATMENT OF URODYNAMIC STRESS INCONTINENCE AT 2 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271637 SUTURE UNKNOWN SUTURE, ABSORBABLE GAK ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention