BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VYPRO MESH UNKNOWN PRODUCT

    MDR report key: 18791582 · Received February 27, 2024

    Report

    Report Number
    2210968-2024-02008
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    November 3, 2021
    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 2210968-2024-02008 AND 2210968-2024-02009. CITATION: J AM COLL SURG. VOL 234:311¿325. HTTPS://DOI.ORG/10.1097/XCS.0000000000000060

    Description of Event or Problem · 0

    TITLE : ASSOCIATION OF MESH AND FIXATION OPTIONS WITH REOPERATION RISK AFTER LAPAROSCOPIC GROIN HERNIA SURGERY: A SWEDISH HERNIA REGISTRY STUDY OF (B)(4) TOTALLY EXTRAPERITONEAL AND TRANSABDOMINAL PREPERITONEAL REPAIRS THE OBJECTIVE OF THIS STUDY WAS NOT TO PINPOINT FACTUAL RECURRENCE RATES, BUT TO DEFINE RELATIVE RISK DIFFERENCES DEPENDING ON THE MESH AND THE FIXATION. BETWEEN (B)(6) 2005, AND (B)(6) 2017, ALL TEP AND TAPP ( N= 25,190 ) REGISTERED IN THE SWEDISH HERNIA REGISTRY 2005 TO 2017 WITH STANDARD POLYPROPYLENE (STDPPM) OR LIGHTWEIGHT (LWM) FLAT MESH, HAVING TACK, FIBRIN GLUE, OR NO FIXATION, WERE INCLUDED IN THE STUDY. SHR FURTHER REGISTERS 3 LIGHTWEIGHT COMPOSITE POLYPROPYLENE-BASED MESH OPTIONS FOR LAPAROSCOPIC REPAIR BY THEIR BRAND NAMES, VYPRO AND ULTRAPRO (ETHICON), AND TIMESH (PFM MEDICAL). THE REPORTED COMPLICATION INCLUDED RECURRENT HERNIA (N=294 ). IN CONCLUSION, WITH STDPPM, NEITHER MECHANICAL NOR GLUE FIXATION SEEMED TO IMPROVE OUTCOMES. THUS, FOR THIS MESH CATEGORY, WE RECOMMEND NONFIXATION. WITH LWM, WE RECOMMEND FIBRIN GLUE FIXATION, WHICH WAS THE ONLY LWM ALTERNATIVE ON PAR WITH NONAFFIXED STDPPM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565051 VYPRO MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention