BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH UNKNOWN PRODUCT

    MDR report key: 8584058 · Received May 6, 2019

    Report

    Report Number
    2210968-2019-81076
    Event Type
    Injury
    Date Received
    May 6, 2019
    Report Date
    April 12, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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: SURG ENDOSC (2017); 31:S312¿S461. DOI: 10.1007/S00464-017-5565-2.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: FACTORS ASSOCIATED WITH RECURRENCE AFTER LAPAROSCOPIC INCISIONAL HERNIA REPAIR. RECENT REVIEWS HAVE INDICATED THAT THE RECURRENCE RATE AFTER LAPAROSCOPIC REPAIR OF INCISIONAL HERNIA IS 3¿4%. MANY FACTORS WERE CONSIDERED ASSOCIATED WITH RECURRENCE. THIS REPORT PROVIDES THE AUTHOR¿S OPINION ABOUT THIS MATTER, WHICH EMERGED FROM THE ANALYSIS OF THE SERIES. FROM SEPTEMBER 2012 TO DECEMBER 2015, 51 PATIENTS UNDERWENT LAPAROSCOPIC REPAIR OF INCISIONAL HERNIA. IN ALL PROCEDURES, A PHYSIOMESH FLEXIBLE COMPOSITE MESH (ETHICON) WILL OVERLAP THE MARGINS OF THE DEFECT BY AT LEAST 5 CM, AND WILL BE FIXED WITH A DOUBLE RING OF ABSORBABLE TACKS ALONE. REPORTED COMPLICATION INCLUDED HERNIA RECURRENCE (N-3). IN CONCLUSION, THE EXPERIENCE SUPPORTS THE CONCEPT THAT INSUFFICIENT COVERAGE OF THE INCISION SCAR BY MESH IS A RISK FACTOR FOR RECURRENCE BECAUSE THE ENTIRE INCISION HAS A POTENTIAL FOR HERNIA DEVELOPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375208 PHYSIOMESH UNKNOWN PRODUCT MESH, SURGICAL FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R