BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDINAL TAPER STYLE MULTI-TIP MARKER

    MDR report key: 2987926 · Received February 21, 2013

    Report

    Report Number
    1836161-2013-00037
    Event Type
    Other
    Date Received
    February 21, 2013
    Date of Event
    November 9, 2010
    Report Date
    February 21, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FZZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. RESULTS: NOT ABLE TO EVALUATE AS PRODUCT NOT RETURNED. CONCLUSIONS: INCONCLUSIVE AS NO EVAL PERFORMED.

    Description of Event or Problem · 1

    THE TIP OF THE PEN WAS TOO SHARP AND IT CUT THE NECK OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75218 CARDINAL TAPER STYLE MULTI-TIP MARKER MULTI-TIP SKIN MARKER FZZ ASPEN SURGICAL PRODUCTS, INC. 2010-04-10

    Patients

    Seq Age Sex Outcome Treatment
    1