BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS ECP

    MDR report key: 7645574 · Received June 27, 2018

    Report

    Report Number
    MW5078116
    Event Type
    Injury
    Date Received
    June 27, 2018
    Date of Event
    June 19, 2018
    Report Date
    June 25, 2018
    Manufacturer
    MALLINCKRODT PHARMACEUTICALS
    Product Code
    LNR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVING EXTRACORPOREAL PHOTOPHERESIS (ECP) FOR GVHD AFTER BMT. HAD INCREASING SOB AND WAS FOUND TO HAVE BILATERAL PES BY V/Q SCAN. PER THE FDA'S LETTER TO HEALTHCARE PROVIDERS, I AM REPORTING THIS. THERE IS NOTHING SPECIFIC TO MAKE US THINK THAT THE ECP LED TO THE PE, WE ARE REPORTING SINCE ASKED BY THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486745 THERAKOS ECP EXTRACORPOREAL PHOTOPHERESIS LNR MALLINCKRODT PHARMACEUTICALS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other