BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPIDPOINT COAG PT LEVEL 2 CONTROL

    MDR report key: 540377 · Received August 17, 2004

    Report

    Report Number
    1217157-2004-00007
    Event Type
    Injury
    Date Received
    August 17, 2004
    Date of Event
    August 9, 2004
    Report Date
    August 17, 2004
    Manufacturer
    BAYER CORP.
    Product Code
    GKP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER WAS INJURED WHILE RECONSTITUTING PT LEVEL 2 CONTROL. TECHNICIAN DID NOT RECEIVE ANY MEDICAL ATTENTION BESIDES RINSING AREA WITH SOAP AND WATER AND COVERING WITH BANDAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDPOINT COAG PT LEVEL 2 CONTROL COAGULATION QC CONTROLS GKP BAYER CORP. NA 220080301

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other