BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMA

    MDR report key: 3952916 · Received July 23, 2014

    Report

    Report Number
    9616240-2014-00003
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 17, 2011
    Report Date
    July 23, 2014
    Manufacturer
    GAMBRO DASCO S.P.A
    Product Code
    KDI
    PMA / PMN Number
    K062090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRISMA MACHINE, SERIAL NUMBER (B)(4), WAS SOLD TO FRESENIUS MEDICAL CARE IN (B)(6) 2003. BASED ON GAMBRO TECHNICAL SERVICE RECORDS, THERE WAS NO REQUEST FOR TECHNICAL ASSISTANCE OR SERVICE FOR THIS MACHINE SINCE 2011. LIMITED INFORMATION HAS BEEN PROVIDED REGARDING THIS EVENT OCCURRING IN 2011.

    Description of Event or Problem · 1

    GAMBRO RECEIVED A NOTICE FROM A LAW FIRM ALLEGING A PERSONAL INJURY CLAIM INVOLVING A PRISMA MACHINES ((B)(4)). THERE WAS NO ADDITIONAL INFORMATION PROVIDED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430544 PRISMA DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO DASCO S.P.A PRISMA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other