BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM UNKNOWN PRODUCT

    MDR report key: 8451878 · Received March 26, 2019

    Report

    Report Number
    2210968-2019-79552
    Event Type
    Injury
    Date Received
    March 26, 2019
    Report Date
    February 26, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K984220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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: FOLIA MEDICA CRACOVIENSIA. 2008 ; 49 (1-2) :49-55 / HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/?TERM=19140491. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: TREATMENT OF THE INGUINAL HERNIAS WITH THE USE OF SYNTHETIC MESH WITH PROLENE HERNIA SYSTEM (PHS) AND ROBBINS-RUTKOW METHODS--REVIEW OF OUTCOMES. THE PURPOSE OF THIS STUDY IS TO EVALUATE THE METHODS AND OUTCOMES OF INGUINAL REGION HERNIAS' TREATMENT WITH THE USE OF SYNTHETIC IMPLANTS. BETWEEN 1999 AND 2005, A TOTAL OF 867 PATIENTS (N=695 MEN, N=172 WOMEN, AVERAGE AGE N=44.5 YEARS) UNDERWENT SURGICAL TREATMENTS OF THE INGUINAL REGION HERNIAS USING SYNTHETIC IMPLANTS. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: PHS GROUP (N=363) AND ROBBINS-RUTKOW GROUP (N=504). IN THE REPAIR OF INGUINAL HAERNIAS, PROLENE HERNIA SYSTEM WAS USED WITH PATIENTS UNDER PHS GROUP. POSTOPERATIVE COMPLICATIONS INCLUDED SUPPURATION OF THE WOUND (N=17), HEMATOMA IN THE WOUND (N=8) AND RELAPSE OF HERNIA (N=4). ANALYSING BOTH METHODS OF TREATMENT, NO STATISTICALLY SIGNIFICANT DIFFERENCES WERE FOUND IN THE FREQUENCY OF POSTOPERATIVE COMPLICATIONS AND HERNIA RELAPSE. THE CHOICE OF METHOD IS DEPENDENT ON THE TYPE OF HERNIA FOUND INTRA-OPERATIVELY. MOREOVER, THE PROPER METHOD CHOICE GUARANTEES THE EFFICACY OF TREATMENT AS WELL AS LITTLE AMOUNT OF COMPLICATIONS AND RELAPSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244916 PROLENE HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention