BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8891352 · Received August 13, 2019

    Report

    Report Number
    2210968-2019-85520
    Event Type
    Injury
    Date Received
    August 13, 2019
    Report Date
    July 17, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. CITATION: HERNIA. 2010; 14: 35¿38 DOI: 10.1007/S10029-009-0556-4. (B)(4).

    Description of Event or Problem · 1

    TITLE: MANAGEMENT OF COMPLICATED UMBILICAL HERNIAS IN CIRRHOTIC PATIENTS USING PERMANENT MESH: RANDOMIZED CLINICAL TRIAL THE OPTIMAL MANAGEMENT OF COMPLICATED UMBILICAL HERNIA IN PATIENTS WITH LIVER CIRRHOSIS IS STILL UNDEFINED. THE PURPOSE OF THIS STUDY IS TO EVALUATE THE USE OF POLYPROPYLENE MESH TO TREAT COMPLICATED UMBILICAL HERNIA IN CIRRHOTIC PATIENTS. IN THE PERIOD FROM JANUARY 2005 TO MAY 2008, A TOTAL OF 72 PATIENTS WITH COMPLICATED UMBILICAL HERNIA COMBINED WITH LIVER CIRRHOSIS UNDERWENT HERNIA REPAIR AND WERE INCLUDED IN THE STUDY. THE PATIENTS WERE RANDOMLY DIVIDED INTO TWO GROUPS; HERNIA REPAIR WAS CARRIED OUT BY CONVENTIONAL FASCIAL REPAIR IN GROUP I (35 PATIENTS; 29 MALE AND 6 FEMALE PATIENTS; MEAN AGE: 50.6 ± 8.29) AND BY MESH HERNIOPLASTY IN GROUP II (37 PATIENTS; 28 MALE AND 9 FEMALE PATIENTS; MEAN AGE: 51.4 ± 5.67). HERNIOPLASTY WAS DONE IN GROUP II USING THE ONLAY NON-ABSORBABLE PROLINE POLYPROPYLENE MESH (ETHICON). IN GROUP II, REPORTED COMPLICATIONS INCLUDED HEMATOMA/SEROMA (N-4), TRANSIENT ASCITIC FLUID LEAKAGE (N-4), SURGICAL SITE INFECTION (N-6) WHICH WAS CONTROLLED BY CONSERVATIVE MANAGEMENT, AND HERNIA RECURRENCE (N-1). THE PLACEMENT OF PERMANENT MESH PROSTHESES IN COMPLICATED HERNIAS IN CIRRHOTIC PATIENTS CAN BE PERFORMED WITH MINIMAL WOUND-RELATED MORBIDITY. THE UTILIZATION OF PERMANENT MESH IN THESE HERNIAS IS ASSOCIATED WITH A SIGNIFICANTLY LOWER RATE OF RECURRENCE AND REDUCES THE NEED FOR FURTHER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684872 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention