BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETEX PRODUCT

    MDR report key: 8768015 · Received July 8, 2019

    Report

    Report Number
    1219930-2019-03969
    Event Type
    Injury
    Date Received
    July 8, 2019
    Date of Event
    February 6, 2008
    Report Date
    July 8, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE OF ARTICLE: LAPAROSCOPIC REPAIR OF SUPRAPUBIC INCISIONAL HERNIAS: SUTURING AND INTRAPERITONEAL COMPOSITE MESH ONLAY. A RETROSPECTIVE STUDY SOURCE: HERNIA (2008) 12:251¿256, RECEIVED: 31 MAY 2007 / ACCEPTED: 9 JANUARY 2008 / PUBLISHED ONLINE: 6 FEBRUARY 2008 © SPRINGER-VERLAG 2008. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, AFTER VENTRAL HERNIA REPAIR, 17 PATIENTS RECEIVED MESH. COMPLICATIONS WERE SEEN IN FIVE PATIENTS, AND INCLUDED DEEP VENOUS THROMBOSIS¿1, PAIN GREATER THAN 5 WEEKS¿1, AND SEROMA¿3. THE SEROMAS SPONTANEOUSLY RESOLVED IN 3¿6 WEEKS, WHILE ONE PATIENT NEEDED ASPIRATION. FIVE PATIENTS HAD RECURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563784 UNKNOWN PARIETEX PRODUCT MESH, SURGICAL, POLYMERIC FTL COVIDIEN LP LLC NORTH HAVEN UNKNOWN PARIETEX PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening