BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE UNKNOWN PRODUCT

    MDR report key: 11178990 · Received January 15, 2021

    Report

    Report Number
    2210968-2021-00411
    Event Type
    Injury
    Date Received
    January 15, 2021
    Date of Event
    January 1, 2019
    Report Date
    December 29, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. ATTEMPTS ARE BEING MADE TO CLARIFY 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER FOR EACH PATIENT? DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (GYNEMESH) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (GYNEMESH) INVOLVED? PATIENT DEMOGRAPHICS? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: (B)(6). J. UROL. 110(2): 112-118, 2019. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    TITLE: LSC VERSUS UPHOLD TYPE TVM: A CASE CONTROLS STUDY. THE PURPOSE OF THIS STUDY IS TO CONDUCT A COMPARATIVE INVESTIGATION OF THE SHORT-TERM TREATMENT OUTCOMES OF UPHOLD-TYPE TRANSVAGINAL MESH (TVM) SURGERY AND LAPAROSCOPIC SACROCOLPOPEXY (LSC) SURGERY. FROM MAY2017 TO DEC2017, 62 FEMALE PATIENTS WITH PELVIC ORGAN PROLAPSE UNDERWENT SURGERY AND WERE ALLOCATED INTO TWO SURGICAL PROCEDURES: UPHOLD TYPE TVM SURGERY (N=25; AGE OF 77.0 ± 6.0 [63-88] YEARS AND LSC SURGERY (N=37; AGE OF 70 ± 5.0 [61-79] YEARS. IN THE LSC GROUP, GYNE MESH PS WAS USED AS THE MESH. IN THE LSC GROUP, POSTOPERATIVE COMPLICATIONS INCLUDED DE NOVO OVERACTIVE BLADDER SYMPTOM (OAB) (N=1), DE NOVO STRESS URINARY INCONTINENCE (SUI) (N=11) AND WORSENED SUI (N=2). TENSION-FREE VAGINAL TAPE (TVT) WAS ADDED IN TWO PHASES IN ONE CASE IN THE LSC GROUP WHERE THE PATIENT DEVELOPED DE NOVO SUI. OAB SCORE, TOTAL URINARY URGENCY, INTERNATIONAL PROSTATE SYMPTOM SCORE AND RESIDUAL URINE WERE IMPROVED IN BOTH GROUPS. BOTH TYPES OF SURGERY ARE EXPECTED TO IMPROVE LOWER URINARY SYMPTOMS AND CONSIDERED TO BE USEFUL TOOL FOR TREATMENT OF PELVIC ORGAN PROLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73582 GYNECARE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1