BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VYPRO MESH UNKNOWN PRODUCT

    MDR report key: 18791475 · Received February 27, 2024

    Report

    Report Number
    2210968-2024-02001
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    February 15, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K002672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2024-02001, 2210968-2024-02002, 2210968-2024-02003 CITATION: ACTA OBSTET GYNECOL SCAND. VOL 101:532¿541.DOI: 10.1111 PLEASE SEE ARTICLE ATTACHED.

    Description of Event or Problem · 0

    TITLE : RECURRENT SURGERY IN UTERINE PROLAPSE: A NATIONWIDE REGISTER STUDY THIS POPULATION-BASED REGISTER STUDY AIMS TO COMPARE THE RELAPSE RATE IN PATIENTS WITH UTERINE PROLAPSE UNDERGOING HYSTERECTOMY WITH SUSPENSION OR UTERINE-SPARING SURGICAL PROCEDURES WITH REAL WORLD DATA IN A CONTEMPORARY CONTEXT. ALL WOMEN WITH UTERINE PROLAPSE UNDERGOING PROLAPSE SURGERY IN SWEDEN BETWEEN JANUARY 1, 2015 AND DECEMBER 31, 2018, WERE INCLUDED IN THE STUDY. THREE OF THE MESHES USED IN SACROCOLPOPEXY (SCP) AND SACROHYSTEROPEXY (SHP) WERE TWO HEAVY WEIGHT ( PARIETEX, PROSUP & VYPRO®). THE REPORTED COMPLICATIONS INCLUDED RECURRENT PELVIC ORGAN PROLAPSE SURGERY (N=?) IN SACROCOLPOPEXY (SCP) AND SACROHYSTEROPEXY ( SHP ). IN CONCLUSION, IN THIS POPULATION-BASED REGISTER STUDY, THE RELAPSE RATE IN PATIENTS WITH UTERINE PROLAPSE UNDERGOING PROLAPSE SURGERY WAS LOW WITH THE MP, WHICH ALSO SHOWED A REDUCED RATE OF SURGICAL MORBIDITY. BOTH SACROSPINOUS LIGAMENT FIXATION WITH AND WITHOUT LIGHTWEIGHT GRAFT HAD A HIGH RATE (ALMOST 30%) OF 1-YEAR POSTOPERATIVE COMPLICATIONS (INCLUDING PAIN AND MESH EROSION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657225 VYPRO MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other