BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM UNKNOWN PRODUCT

    MDR report key: 8423415 · Received March 14, 2019

    Report

    Report Number
    2210968-2019-79493
    Event Type
    Injury
    Date Received
    March 14, 2019
    Report Date
    March 4, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K984220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: ANZ J. SURG. 2004; 74: 343¿345. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE TITLE: SINGLE SURGEON EXPERIENCE WITH BILAYER POLYPROPELENE MESH REPAIR OF INGUINAL HERNIA OPEN MESH REPAIR OF INGUINAL HERNIA HAS BEEN SHOWN TO BE AN EFFECTIVE AND SAFE METHOD OF HERNIA REPAIR. IN SEARCH OF THE ¿IDEAL¿ METHOD OF OPEN MESH HERNIA REPAIR, MANY DIFFERENT METHODS OF MESH PLACEMENT HAVE BEEN DEVELOPED. THE PRESENT STUDY REPORTS THE SINGULAR EXPERIENCE OF A GENERAL SURGEON WITH THIS BILAYER POLYPROPYLENE MESH IMPLANT. THIS RETROSPECTIVE AUDIT OF THE FIRST 169 CONSECUTIVE INGUINAL HERNIA REPAIRS (AGE RANGE: 21 TO 99 YEARS OLD; MALE TO FEMALE RATIO: 95:8) USING THE BILAYER POLYPROPYLENE HERNIA SYSTEM (PHS; ETHICON) WAS CONDUCTED BY MAILED QUESTIONNAIRE AND TELEPHONE INTERVIEW. REPORTED COMPLICATIONS INCLUDED PERSISTENT DISCOMFORT/PAIN (21%), PAIN (N-2) WHICH REQUIRED MEDICATION, WOUND INFECTION (N-5), WHICH REQUIRED ORAL ANTIBIOTICS BY THE OPERATING SURGEON IN 2 PATIENTS AND THE REMAINING 3 PATIENTS WERE TREATED BY THE GENERAL PRACTITIONER, WOUND ABSCESS (N-1) WHICH REQUIRED WOUND EXPLORATION POST-OPERATIVELY IN THE OPERATING THEATRE, WOUND HEMATOMA (N-1) WHICH REQUIRED WOUND EXPLORATION POST-OPERATIVELY IN THE OPERATING THEATRE, AND RECURRENT HERNIA (N-1) WHICH WAS REPAIRED BY ANOTHER SURGEON. THE PRESENT REVIEW SHOWS THAT THE TECHNIQUE OF BILAYER MESH HERNIOPLASTY FOR PRIMARY OR RECURRENT INGUINAL HERNIA IS SAFE AND IS ASSOCIATED WITH LOW RECURRENCE AND COMPLICATION RATES. BROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216618 PROLENE HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention