BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHARD-ALLAN REGULAR TIP PEN W/ RULER

    MDR report key: 6066731 · Received October 31, 2016

    Report

    Report Number
    1836161-2016-00099
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    September 12, 2016
    Report Date
    October 3, 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 ON K67-09-39 THAT 2 PCS HAD PACKING FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717570 RICHARD-ALLAN REGULAR TIP PEN W/ RULER MARKING PEN FZZ ASPEN SURGICAL PRODUCTS, CALEDONIA 2650 102876

    Patients

    Seq Age Sex Outcome Treatment
    1