BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOMARK2 8 MR BIOSITE INDENT

    MDR report key: 1231188 · Received November 10, 2008

    Report

    Report Number
    3005075853-2008-02890
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 16, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    FZP
    PMA / PMN Number
    K003777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE TIP BROKE OFF. ANOTHER DEVICE WAS USED TO MARK THE SITE. NO CONSEQUENCE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOMARK2 8 MR BIOSITE INDENT FZP ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1