BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMA PRE SET

    MDR report key: 3131291 · Received April 9, 2006

    Report

    Report Number
    8010182-2006-00021
    Event Type
    Malfunction
    Date Received
    April 9, 2006
    Date of Event
    August 4, 2006
    Report Date
    August 31, 2006
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    FJK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ABSENCE OF INCRIMINATED SAMPLE FOR INVESTIGATION (SAMPLE ASKED BUT NOT RECEIVED). ABSENCE OF FURTHER INFORMATION FROM THE CLINIC INVOLVED. INCIDENT STILL UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE ESTABLISHED AND FORWARDED TO THE FDA.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA PRE SET PRISMA M100 PRESET FJK GAMBRO INDUSTRIES M 100 PRESET 06A0554G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other