BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETRACE

    MDR report key: 319192 · Received February 28, 2001

    Report

    Report Number
    2951268-2001-00001
    Event Type
    Malfunction
    Date Received
    February 28, 2001
    Report Date
    February 28, 2001
    Manufacturer
    WYNDGATE TECHNOLOGIES / DIV GLOBAL MED TECHNOLOGIES, INC.
    Product Code
    MMH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A, PRODUCT SAFETY ADVISORY ST-01-03, SENT 2/12/2001 TO ALL USERS. B, PRODUCT SAFETY ADVISORY ST-01-03 (REVISED) SENT 2/16/2001 TO ALL USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8239 SAFETRACE SOFTWARE, BLOOD BANK DONOR, STANDALONE MMH WYNDGATE TECHNOLOGIES / DIV GLOBAL MED TECHNOLOGIES, INC. 1.1 - 1.3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *