BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHARD-ALLAN REGULAR TIP PEN W/ RULER

    MDR report key: 6121105 · Received November 22, 2016

    Report

    Report Number
    1836161-2016-00104
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 25, 2016
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    FZZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT 1 PC HAD A PACKING FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771254 RICHARD-ALLAN REGULAR TIP PEN W/ RULER MARKING PEN FZZ ASPEN SURGICAL PRODUCTS, CALEDONIA 2650 107575

    Patients

    Seq Age Sex Outcome Treatment
    1