BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE UNKNOWN PRODUCT

    MDR report key: 20336120 · Received September 30, 2024

    Report

    Report Number
    2210968-2024-10407
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    March 7, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    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? 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: JOURNAL OF HEALTHCARE ENGINEERING, VOLUME 2022, ARTICLE ID 1557256, 9 PAGES. HTTPS://DOI.ORG/10.1155/2022/1557256.

    Description of Event or Problem · 0

    TITLE: CLINICAL EFFICACY OF LSC AND TVT-O FOR STRESS URINARY INCONTINENCE COMPLICATED WITH PELVIC ORGAN PROLAPSE AND FACTORS INFLUENCING POSTOPERATIVE URINARY FUNCTION RECOVERY. THE AIM OF THIS STUDY WAS TO CLARIFY THE CLINICAL EFFECT OF LAPAROSCOPIC SACROCOLPOPEXY (LSC) AND TENSION-FREE VAGINAL TAPE OBTURATOR (TVT-O) FOR STRESS URINARY INCONTINENCE (SUI) COMPLICATED WITH PELVIC ORGAN PROLAPSE (POP) AND THE INFLUENCING FACTORS OF POSTOPERATIVE URINARY FUNCTION (UF)RECOVERY. A TOTAL OF (B)(4) PATIENTS WITH SUI COMPLICATED WITH POP TREATED IN (B)(6) HOSPITAL AND (B)(6) HOSPITAL BETWEEN (B)(6) 2018 AND (B)(6) 2019 WERE RETROSPECTIVELY ANALYZED. PATIENTS WERE ASSIGNED TO THE FOLLOWING TWO ARMS BASED ON DIFFERENT TREATMENT METHODS: THE COMBINATION GROUP (N = 65, TREATED WITH LSC PLUS TVT-O) AND THE CONTROL GROUP (N = 60, TREATED WITH LSC). THE AVERAGE AGE WERE 40.3 ± 5.1 YEARS AND 40.1 ± 5.6 YEARS FOR THE CONTROL AND COMBINATION GROUP, RESPECTIVELY. LSC WAS PERFORMED USING THE MESH (GYNECARE GYNEMESH¿ PS, POLYPROPYLENE MESH, JOHNSON & JOHNSON COMPANY, USA). REPORTED COMPLICATIONS COMBINATION GROUP INCLUDE INEFFECTIVE/NON-DISAPPEARANCE OF SYMPTOMS (N= 3), DEFECATION DISCOMFORT (N=1), INFECTION (N=1), AND DYSURIA (N=2). WHILE IN THE CONTROL GROUP INCLUDE INEFFECTIVE/NON-DISAPPEARANCE OF SYMPTOMS (N=6), RECURRENCE (N=4), DEFECATION DISCOMFORT (N=2), INFECTION (N=3), DYSURIA (N=3), AND BLADDER INJURY (N=3). IN CONCLUSION, FOR PATIENTS WITH SUI COMPLICATED WITH POP, THE EFFICACY OF LAPAROSCOPIC SACROCOLPOPEXY WAS LIMITED, WHILE COMBINING WITH TVT-O WOULD OBTAIN MORE SIGNIFICANT SHORT-TERM AND LONG-TERM EFFICACY, WHICH CAN SIGNIFICANTLY IMPROVE PATIENTS¿ URINATION AND LONG-TERM QUALITY OF LIFE, WITH HIGHER SAFETY AND CLINICAL PROMOTION VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997954 GYNECARE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other