BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPIDPOINT COAG PT LEVEL 2 CONTROL

    MDR report key: 531179 · Received June 24, 2004

    Report

    Report Number
    1217157-2004-00005
    Event Type
    Injury
    Date Received
    June 24, 2004
    Date of Event
    April 9, 2004
    Report Date
    June 21, 2004
    Manufacturer
    BAYER CORP
    Product Code
    GGN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER WAS INJURED WHILE RECONSTITUTING PT LEVEL 2 CONTROL. THEY USED PROTECTIVE SLEEVE HOWEVER GLASS CHARDS PIERCED GLOVE AND CUT SKIN OF LEFT THUMB. TECHNICIAN DID NOT RECEIVE ANY MEDICAL ATTENTION BESIDES RINSING AREA WITH SOAP AND WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDPOINT COAG PT LEVEL 2 CONTROL COAGULATION QC CONTROLS GGN BAYER CORP NA 220030301

    Patients

    Seq Age Sex Outcome Treatment
    1 *