BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH, SURGICAL, POLYMERIC

    MDR report key: 6647075 · Received June 16, 2017

    Report

    Report Number
    9617613-2017-05097
    Event Type
    Injury
    Date Received
    June 16, 2017
    Report Date
    June 9, 2017
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BERREVOET F; DOERHOFF C; MUYSOMS F; HOPSON S; MUZI MG; NIENHUIJS S; KULLMAN E; TOLLENS T; SCHWARTZ MR; LEBLANC K; VELANOVICH V; JORGENSEN LN; (2017) A MULTICENTER PROSPECTIVE STUDY OF PATIENTS UNDERGOING OPEN VENTRAL HERNIA REPAIR WITH INTRAPERITONEAL POSITIONING USING THE MONOFILAMENT POLYESTER COMPOSITE VENTRAL PATCH: INTERIM RESULTS OF THE PANACEA STUDY.MEDICAL DEVICES EVIDENCE AND RESEARCH. 10:81-88, 2017 PURPOSE: THIS STUDY ASSESSED THE RECURRENCE RATE AND OTHER SAFETY AND EFFICACY PARAMETERS FOLLOWING VENTRAL HERNIA REPAIR WITH A POLYESTER COMPOSITE PROSTHESIS (PARIETEX¿ COMPOSITE VENTRAL PATCH [PCO-VP]). PATIENTS AND METHODS: A SINGLE-ARM, MULTICENTER PROSPECTIVE STUDY OF 126 PATIENTS UNDERGOING OPEN VENTRAL HERNIA REPAIR WITH THE PCO-VP WAS PERFORMED. A TOTAL OF 126 PATIENTS WERE ENROLLED BETWEEN MAY 3, 2013, AND JULY 10, 2014, AT 12 CENTERS IN EUROPE AND THE US. THE MAJORITY (87.3%) OF PATIENTS WAS TREATED FOR AN UMBILICAL HERNIA, WHILE 12.7% WERE TREATED FOR EPIGASTRIC HERNIA. POSTOPERATIVE HEMATOMA - 2 (1.6%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427049 MESH, SURGICAL, POLYMERIC FTL TISSUE SCIENCE LABORATORIES UNKNOWN PARIETEX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other