BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 25152164 · Received May 12, 2026

    Report

    Report Number
    2210968-2026-05178
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    May 13, 2025
    Report Date
    May 22, 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
    GG
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. 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: UPDATES SURG. 2025 SEP;77(5):1657-1664. HTTPS://DOI.ORG/10.1007/S13304-025-02229-7 EPUB 2025 MAY 13. PMID: 40360803.

    Description of Event or Problem · 0

    TITLE: ANTERIOR COMPONENT SEPARATION VERSUS POSTERIOR COMPONENT SEPARATION WITH TRANSVERSUS ABDOMINIS RELEASE FOR LARGE VENTRAL HERNIAS: A RANDOMIZED CONTROLLED STUDY. THE AIM OF THIS STUDY IS TO ANALYZE OUTCOMES OF OPEN ANTERIOR COMPONENT SEPARATION TECHNIQUE (ACST) N=2 AND POSTERIOR COMPONENT SEPARATION TECHNIQUE WITH TRANSVERSUS ABDOMINIS RELEASE (TAR) FOR MIDLINE LARGE VENTRAL HERNIAS. FROM DECEMBER 2016 TO JULY 2022. DATA OF 43 PATIENTS (22 PATIENTS FROM ACST GROUP AND 21-FROM TAR GROUP) WERE ANALYZED. PROLENE MESH (ETH) WAS USED FOR ALL SURGICAL INTERVENTIONS IN BOTH GROUPS. REPORTED COMPLICATIONS: PROLENE MESH (ETH) ACST GROUP (N=22) SURGICAL SITE OCCURRENCE (SSO) (N=11) TREATMENT: NOT REPORTED SURGICAL SITE INFECTION (SSI) (N=1) TREATMENT: NOT REPORTED SEROMA (N=9) TREATMENT: NOT REPORTED WOUND DEHISCENCE AND SKIN NECROSIS (N=1) TREATMENT: NOT REPORTED DEEP VEIN THROMBOSIS (N=1) TREATMENT: NOT REPORTED HERNIA RECURRENCE (N=1) TREATMENT: NOT REPORTED TAR GROUP (N=21) SURGICAL SITE OCCURRENCE (SSO) (N=4) TREATMENT: NOT REPORTED SURGICAL SITE INFECTION (SSI) (N=1) TREATMENT: NOT REPORTED SEROMA (N=2) TREATMENT: NOT REPORTED WOUND DEHISCENCE AND SKIN NECROSIS (N=1) TREATMENT: NOT REPORTED DEEP VEIN THROMBOSIS (N=1) TREATMENT: NOT REPORTED HERNIA RECURRENCE (N=1) TREATMENT: NOT REPORTED. IN CONCLUSION, THE STUDY REVEALED THAT WHEN COMPARING THE ACST AND TAR GROUPS FOR LARGE MIDLINE VENTRAL HERNIA, THERE WAS NO SIGNIFICANT DIFFERENCE IN TERMS OF HERNIA RECURRENCE AND QOL. TAR IS ASSOCIATED WITH SIGNIFICANTLY LESS SSO THAN ACST. THIS CAN BE CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525758 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other