BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT AUTO CLINICAL SAFETY LANCET - NORMAL

    MDR report key: 5018702 · Received August 12, 2015

    Report

    Report Number
    1058955-2015-00015
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    April 5, 2010
    Report Date
    August 5, 2015
    Manufacturer
    STAT MEDICAL DEVICES, INC.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL (B)(4), FOR THIS PRODUCT RETURN WAS CLOSED ON (B)(6) 2014. THIS NEW (B)(4) WAS OPENED AFTER CONSULTATION WITH THE EMERGO GROUP ON THE RE-ASSESSMENT OF THE MDR SUBMISSION FOR THIS RETURNED PRODUCT.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531140 STAT AUTO CLINICAL SAFETY LANCET - NORMAL AUTO NORMAL FMK STAT MEDICAL DEVICES, INC. SAN-100 00117

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other