BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRIP LPG 1510

    MDR report key: 7573015 · Received June 5, 2018

    Report

    Report Number
    MW5077656
    Event Type
    Injury
    Date Received
    June 5, 2018
    Date of Event
    November 30, 2017
    Report Date
    June 4, 2018
    Manufacturer
    COVIDIEN
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HERNIA SURGERY (B)(6) 2017 PAIN AFTER A WEEK OR TWO, PROGRIP MESH USED. WENT TO NEW SURGEON, SECOND SURGERY (B)(6) 2018 TRIED TO REMOVE OPEN INCISION AND REFERRED ME TO THIRD SURGEON TO TRY TO REMOVE LAPAROSCOPICALLY. GOING (B)(6) FOR CONSULT, DR (B)(6) - SECOND SURGEON SAID PAIN CAUSED BY PROGRIP MESH, WANTS IT OUT TO TRY TO HELP THE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411294 PROGRIP LPG 1510 MESH, SURGICAL, POLYMERIC FTL COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention| S