BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 25159945 · Received May 13, 2026

    Report

    Report Number
    2210968-2026-05200
    Event Type
    Injury
    Date Received
    May 13, 2026
    Report Date
    May 13, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. 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: BR J SURG. 1998 OCT;85(10):1415-8. HTTPS://DOI.ORG/10.1046/J.1365-2168.1998.00849.X. PMID: 9782028.

    Description of Event or Problem · 0

    TITLE: REPAIR OF VENTRAL HERNIAS WITH EXPANDED POLYTETRAFLUOROETHYLENE PATCH. BACKGROUND OPERATIONS FOR LARGE AND RECURRENT ABDOMINAL HERNIAS HAVE A HIGH ASSOCIATED RECURRENCE RATE, ALTHOUGH IT IS LOWER WHEN PROSTHETIC MATERIAL IS USED. EXPANDED POLYTETRAFLUOROETHYLENE (EPTFE) SEEMS TO BE THE BEST TOLERATED PROSTHETIC MATERIAL IN SURGERY. A SERIES OF 45 VENTRAL HERNIAS REPAIRED USING EPTFE FOR CLOSURE OR REINFORCEMENT OF THE HERNIORRHAPHY HAS BEEN EVALUATED PROSPECTIVELY. THIRTY-SIX WERE MIDLINE INCISIONAL HERNIAS AND NINE WERE TRANSVERSE OR PARARECTAL VENTRAL HERNIAS. THERE WERE 13 RECURRENT VENTRAL HERNIAS AND THREE DEFECTS WERE OPERATED AS AN EMERGENCY PROCEDURE. THE PATCH WAS SUTURED TO THE ANTERIOR APONEUROSIS WITH A RUNNING NON-ABSORBABLE SUTURE. SOME OTHER KIND OF INTRA-ABDOMINAL PROCEDURE WAS UNDERTAKEN IN 12 CASES. THREE PATIENTS UNDERWENT REPAIR AS AN EMERGENCY PROCEDURE: DEHISCENCE OF A PARARECTAL LAPAROTOMY WOUND FOR A KIDNEY TRANSPLANT, INTESTINAL OBSTRUCTION DUE TO INCARCERATION AND INFECTION OF A PROLENE (ETHICON, EDINBURGH, UK) MESH. SEVEN PATIENTS HAD PREVIOUSLY UNDERGONE REPAIR WITH PROSTHETIC MATERIAL AND WERE REFERRED AFTER HERNIA RECURRENCE: EPTFE PATCH (FOUR PATIENTS WHOSE PROSTHESIS HAD BEEN SUTURED WITH INTERRUPTED STITCHES, EITHER AS AN ONLAY OR SUBFASCIAL HERNIORRHAPHY), PROLENE MESH (TWO) AND LYODURA (B/BRAUN, MELSUNGEN, GERMANY) PATCH (ONE). REPORTED COMPLICATIONS INCLUDE: PROLENE MESH (ETHICON) INFECTION OF PROLENE MESH (N=1) TREATMENT: EMERGENCY HERNIORRHAPHY HERNIA RECURRENCE (N=2) TREATMENT: RE-OPERATION. IN CONCLUSION, THIS CLINICAL EXPERIENCE SHOWS THAT EPTFE IS A VERY RELIABLE PROSTHETIC MATERIAL FOR THE REPAIR OF ABDOMINAL WALL HERNIAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611245 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention