BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 22664215 · Received July 30, 2025

    Report

    Report Number
    2210968-2025-08804
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    December 13, 2024
    Report Date
    July 30, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. ATTEMPTS ARE BEING 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: HERNIA. 2024 DEC 13;29(1):47. HTTPS://DOI.ORG/10.1007/S10029-024-03235-1. PMID: 39671013.

    Description of Event or Problem · 0

    TITLE: IS MESH PORE SIZE ASSOCIATED WITH THE OUTCOME IN LAPARO-ENDOSCOPIC INGUINAL HERNIA REPAIR? - A REGISTRY-BASED MULTIVARIABLE ANALYSIS. THE AIM OF THIS RETROSPECTIVE STUDY IS TO ANALYZE THE ASSOCIATION BETWEEN MESH PORE SIZE AND THE OUTCOME IN LAPARO-ENDOSCOPIC INGUINAL REPAIR, IT WAS NECESSARY TO SELECT MESHES WITH COMPARABLE PROPERTIES. AS OF 31 JANUARY 2022, IN TOTAL, 83,768 PATIENTS WERE INCLUDED IN THIS RETROSPECTIVE ANALYSIS. OF THESE PATIENTS, 61,891 (73.9%) UNDERWENT LAPAROENDOSCOPIC INGUINAL HERNIA REPAIR USING A LARGE-PORE MESH AND 21,877 (26.1%) USING A SMALL-PORE MESH. 19,077 MALES AND 2800 FEMALES IN SMALL PORE SIZE GROUP WITH THE MEAN AGE OF 21,877 / 57.1PLUS OR MINUS 15.8 YEARS AND 54,753 MALES AND 7138 FEMALES IN LARGE PORE SIZE GROUP WITH MEAN AGE OF 61,891 / 58.5 PLUS OR MINUS 15.2 YEARS. 4 PATIENTS USED ETHICON ENDOROLL PROLENE MESH IN SMALL PORE SIZE GROUP USED FOR LAPARO-ENDOSCOPIC INGUINAL HERNIA REPAIR. THE MEAN DURATION FOLLOW-UP IS 1 YEAR. REPORTED COMPLICATIONS: ENDOROLL PROLENE MESH (ETHICON): (N=?) INTRAOPERATIVE COMPLICATIONS. TREATMENT: REOPERATION. (N=?) GENERAL COMPLICATIONS. TREATMENT: REOPERATION. (N=?) POSTOPERATIVE COMPLICATIONS. TREATMENT: REOPERATION. (N=?) RECURRENCE AT 1-YEAR FOLLOW-UP. TREATMENT: NOT REPORTED. (N=?) PAIN ON EXERTION AT 1-YEAR FOLLOW-UP. TREATMENT: NOT REPORTED. (N=?) PAIN AT REST AT 1-YEAR FOLLOW-UP. TREATMENT: NOT REPORTED. (N=?) CHRONIC PAIN. TREATMENT: REQUIRING TREATMENT AT 1-YEAR FOLLOW-UP. IN CONCLUSIONS, NO ASSOCIATION WAS IDENTIFIED BETWEEN THE PORE SIZE OF THE MESHES USED IN LAPARO-ENDOSCOPIC INGUINAL REPAIR AND THE RECURRENCE RATE, PAIN ON EXERTION RATE OR THE RATE OF CHRONIC PAIN REQUIRING TREATMENT AT ONE-YEAR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496197 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention