BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8928639 · Received August 23, 2019

    Report

    Report Number
    2210968-2019-86085
    Event Type
    Injury
    Date Received
    August 23, 2019
    Report Date
    July 31, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    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 (2007) 11:25¿29; DOI 10.1007/S10029-006-0141-Z; PUBLISHED ONLINE: 11 NOVEMBER 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: OUTCOMES OF THE RIVES - STOPPA TECHNIQUE IN INCISIONAL HERNIA REPAIR: TEN YEARS OF EXPERIENCE. THIS RETROSPECTIVE STUDY AIMED TO ASSESS THE OUTCOMES OF IRANIAN PATIENTS UNDERGOING THE R¿S TECHNIQUE AND TO DETERMINE FACTORS AFFECTING RECURRENCE RATE AND TIME. BETWEEN 1993 AND 2003, 86 PATIENTS (MEAN AGE 51.21 YEARS, MALES N=20, FEMALE N=66) WHO HAD UNDERGONE THE CLASSIC R¿S TECHNIQUE FOR VENTRAL INCISIONAL HERNIA WERE INCLUDED IN THIS STUDY. TWO TYPES OF MESH WERE USED, PROLENE AND MERSILENE. COMPLICATIONS INCLUDED SEROMA (N=1) IN WHICH FLUID COLLECTION RESOLVED ON ITS OWN; RECURRENT HERNIA (N=5), SUPERFICIAL WOUND INFECTION (N=10) WHICH WAS TREATED WITH ANTIBIOTICS AND LOCAL CARE; DEEP WOUND INFECTION (N=3) IN WHICH ONE PATIENT NEEDED REMOVAL OF THE MESH AND THE OTHER TWO UNDERWENT ANTIBIOTIC THERAPY, MESH INFECTION (N=2) AND INTESTINAL PARTIAL OBSTRUCTION (N=1). IN CONCLUSION, THE R¿S TECHNIQUE IS THE MOST PROMISING OPEN TECHNIQUE, WITH LOW RECURRENCE RATES, EXCELLENT LONG-TIME RESULTS, AND MINIMAL SERIOUS MORBIDITY. AGE MIGHT BE AN IMPORTANT FACTOR IN RECURRENCE RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718524 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention