BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CGH IC-3L (PL/CU/0.8/L)

    MDR report key: 102272 · Received April 24, 1996

    Report

    Report Number
    2243621-1996-05059
    Event Type
    Malfunction
    Date Received
    April 24, 1996
    Date of Event
    May 22, 1993
    Report Date
    January 19, 1996
    Manufacturer
    COBE LABORATORIES
    Product Code
    FJG
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY ALLEGES THAT DIALYZER WAS CRACKED, EBL 75 CC. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CGH IC-3L (PL/CU/0.8/L) * FJG COBE LABORATORIES * 10611N11

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR