BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETEX PROGRIP

    MDR report key: 12121025 · Received July 6, 2021

    Report

    Report Number
    1219930-2021-02671
    Event Type
    Injury
    Date Received
    July 6, 2021
    Date of Event
    January 14, 2020
    Report Date
    July 6, 2021
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: QUALITY OF LIFE AFTER COMPLEX ABDOMINAL WALL RECONSTRUCTION SOURCE: VISC MED 2020;36:326¿332 PUBLISHED ONLINE: JANUARY 14, 2020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, (2011 TO 2016) THIS STUDY AIMED TO ASSESS A RETROSPECTIVE STUDY EVALUATED OUTCOMES OF PATIENTS WHO UNDERWENT HERNIA REPAIR USING EITHER AN OPEN OR ENDOSCOPICALLY ASSISTED COMPONENT SEPARATION TECHNIQUE. THE DISSECTION BALLOON WAS USED IN THE ENDOSCOPIC ASSISTED GROUP. PARIETEX PROGRIP MESH WAS USED. THERE WERE 25 PATIENTS IN THE OPEN GROUP AND 10 PATIENTS IN THE ENDOSCOPIC ASSISTED GROUP. COMPLICATIONS INCLUDED: SEROMA, HEMATOMA, NECROSIS AND SUPERFICIAL AND SUB-FASCIAL COMPLICATIONS. CT GUIDED DRAINAGE WAS REQUIRED TO TREAT ONE PATIENT WITH HEMATOMA/SEROMA. REOPERATIONS AND EXTENDED HOSPITAL STAY WERE REPORTED. QUALITY OF LIFE AFTER COMPLEX ABDOMINAL WALL RECONSTRUCTION I MARK PHILIPP MATTHIAS LEUCHTER ERNST KLAR / RECEIVED: JULY 22, 2019 ACCEPTED: DECEMBER 4, 2019 PUBLISHED ONLINE: JANUARY 14, 2020 / DEPARTMENT OF GENERAL, VISCERAL, VASCULAR, AND TRANSPLANTATION SURGERY, UNIVERSITY MEDICAL CENTER OF ROSTOCK, GERMANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018062 UNKNOWN PARIETEX PROGRIP MESH, SURGICAL, POLYMERIC FTL COVIDIEN LP LLC NORTH HAVEN UNKNOWN PARIETEX PROGRIP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R