BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 25152551 · Received May 12, 2026

    Report

    Report Number
    2210968-2026-05185
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    February 7, 2026
    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 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: HERNIA. 2026 FEB 7;30(1):86. HTTPS://DOI.ORG/10.1007/S10029-025-03577-4 PMID: 41652075.

    Description of Event or Problem · 0

    TITLE: ABDOMINAL WALL RECONSTRUCTION IN COMBINED MIDLINE AND LATERAL HERNIAS. BETWEEN JANUARY 2006 AND JANUARY 2025, 67 CONSECUTIVE PATIENTS WHO UNDERWENT ABDOMINAL WALL RECONSTRUCTION FOR COMBINED MH AND LH OR PARASTOMAL HERNIA (PH) WERE RETROSPECTIVELY ANALYSED. THE ABDOMINAL WALL WAS RECONSTRUCTED USING A COMBINATION OF THE RETROMUSCULAR SUBLAY TECHNIQUE AND THE COMPONENT SEPARATION TECHNIQUE, FOLLOWED BY MESH REINFORCEMENT. THE MAJORITY OF PATIENTS WERE MALE (64.1% AMONG PATIENTS WITH MH AND LH AND 85.7% AMONG PATIENTS WITH PH). THE MEDIAN AGE WAS 61 YEARS IN THE GROUP WITH LH AND 64 YEARS IN THOSE WITH PH. NOTHING HAS BEEN CHANGED IN THE PERIOPERATIVE AND POSTOPERATIVE PROTOCOL, AND OPERATIVE TECHNIQUE, EXCEPT THE MESH TYPE. POLYPROPYLENE MESH WAS USED ROUTINELY - PROLENE MESH (ETHICON, JOHNSON-JOHNSON) AT THE BEGINNING OF THE SERIES, AND THEN PARIETENE MESH PP3030 (COVIDIEN, MEDTRONIC). ULTRAPRO MESH (LIGHT-WEIGHT) WAS USED IN ONLY ONE PATIENT. THIS PROCEDURE IS PERFORMED WITHOUT ANY SPECIAL EQUIPMENT REQUIRED BY LAPAROSCOPIC OR ROBOTIC SURGERY. REPORTED COMPLICATIONS INCLUDE: PROLENE MESH (ETHICON) MORBIDITY (N= 12) TREATMENT: NOT REPORTED SEROMA (N= 3) TREATMENT: NOT REPORTED SKIN NECROSIS (N=5) TREATMENT: NOT REPORTED HEMATOMA (N=2) TREATMENT: NOT REPORTED MESH INFECTION (N=3) TREATMENT: NOT REPORTED MORBIDITY (N= 2) TREATMENT: NOT REPORTED RECURRENCE (N=2) TREATMENT: NOT REPORTED ABDOMINAL WALL BULGING (N=1) TREATMENT: NOT REPORTED IN CONCLUSION, THE COMBINATION OF THE RETROMUSCULAR SUBLAY TECHNIQUE, THE COMPONENT SEPARATION TECHNIQUE AND MESH REINFORCEMENT IS A SAFE AND EFFECTIVE METHOD FOR THE SIMULTANEOUS REPAIR OF MH AND LH OR PH. ULTRAPRO MESH (LIGHT-WEIGHT) WAS USED IN ONLY ONE PATIENT. POST OPERATIVE EVENTS CANNOT SPECIFIED ON A PATIENT WHO USED IT ON THE PROCEDURE. THUS, IT IS EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97675 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other