BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE UNKNOWN PRODUCT

    MDR report key: 20352718 · Received October 2, 2024

    Report

    Report Number
    2210968-2024-10484
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    January 1, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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: HTTPS://DOI.ORG/10.1038/S41598-022-11039-5.

    Description of Event or Problem · 0

    TITLE: ANALYZING THE LEARNING CURVE OF VAGINAL PELVIC RECONSTRUCTION SURGERY WITH AND WITHOUT MESH BY THE CUMULATIVE SUMMATION TEST (CUSUM). WOMEN WHO UNDERWENT VAGINAL PELVIC RECONSTRUCTIVE SURGERY WITH OR WITHOUT MESH CONSECUTIVELY BETWEEN 2004 AND 2018 WERE RETROSPECTIVELY ANALYZED TO DETERMINE THE LEARNING CURVE IN VAGINAL PELVIC RECONSTRUCTIVE SURGERY. THE STUDY IS BASED ON TWO INDIVIDUAL SURGEONS WHO PERFORMED VAGINAL PELVIC RECONSTRUCTIVE SURGERY WITH OR WITHOUT MESH. TWO HUNDRED AND SIXTY-FOUR WOMEN WITH STAGE III OR IV PELVIC ORGAN PROLAPSE UNDERWENT VAGINAL PELVIC RECONSTRUCTIVE SURGERY BY SURGEONS A OR B. A POLYPROPYLENE MESH (GYNEMESH PS NONABSORBABLE PROLENE MESH, ETHICON, US) AND A POLYPROPYLENE MESH (GYNEMESH PS NONABSORBABLE PROLENE MESH, TRIMMED TO A CENTRAL DIAMOND SHAPE WITH TWO SETS OF PAIRED ARMS. APPROPRIATE SKIN HOLES WERE CREATED OUTSIDE THE OBTURATOR FORAMEN ON EACH SIDE WAS THEN TRIMMED TO A CENTRAL DIAMOND SHAPE WITH TWO SETS OF PAIRED ARMS. APPROPRIATE SKIN HOLES WERE CREATED OUTSIDE THE OBTURATOR FORAMEN ON EACH SIDE. THE REPORTED COMPLICATIONS INCLUDED: (N=6) HIGH POSTVOID RESIDUAL URINE, TREATMENT: NOT MENTIONED. (N=1) URINARY TRACT INFECTION, TREATMENT: NOT MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34780 GYNECARE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other