BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORGANON TEK

    MDR report key: 233277 · Received July 23, 1999

    Report

    Report Number
    MW1016812
    Event Type
    Malfunction
    Date Received
    July 23, 1999
    Date of Event
    July 23, 1999
    Report Date
    July 23, 1999
    Manufacturer
    SORB TECHNOLOGY, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM MFR ON 07/26/1999: THE DIALYSIS BUSINESS,PREVIOUSLY OWNED BY ORGANON TEKNIKA, HAS BEEN SOLD TO SORB TECHNOLOGY, INC. PO DRAWER 1217, WEST POINT, MS 38773.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORGANON TEK PORTABLE DIALYSIS MACHINE KDI SORB TECHNOLOGY, INC. 2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other