BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT COMFORT THIN LANCET - TWIST OFF

    MDR report key: 5018691 · Received August 12, 2015

    Report

    Report Number
    1058955-2015-00016
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    October 8, 2013
    Report Date
    August 5, 2015
    Manufacturer
    STAT MEDICAL DEVICES, INC.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL COMPLAINT, (B)(4), FOR THIS PRODUCT RETURN WAS CLOSED ON 06/30/2014. THIS NEW COMPLAINT (B)(4) WAS OPENED AFTER CONSULTATION WITH THE EMERGO GROUP ON THE RE-ASSESSMENT OF TH EMDR SUBMISSION FOR THIS RETURNED PRODUCT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED THAT THE PRINT WAS RUBBING FROM THE POLYBAG. A COMPLEX POLYBAG WAS DEVELOPED, A BASIC POLYBAG WITH PRINTING AFTER WHICH A CLEAR FILM IS ADDED TO THE BAG WILL ELIMINATE HE ISSUE. THE CUSTOMER FINALLY AGREED TO ACCEPT THE COMPLEX POLYBAG FOR USE WITH THIS PRODUCT. THE COMPLEX POLYBAG WAS RELEASED ON CR (B)(4) AND BECAME EFFECTIVE ON 11/08/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528596 STAT COMFORT THIN LANCET - TWIST OFF TWIST OFF LANCET FMK STAT MEDICAL DEVICES, INC. SCU-100 00311B

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other