BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8G MAMMOMARK BREAST MARKER

    MDR report key: 1082910 · Received July 25, 2008

    Report

    Report Number
    3005075853-2008-00677
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 30, 2008
    Report Date
    June 30, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVAL. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE MARKER DEPLOYED SUCCESSFULLY, BUT THE PLASTIC APPLIER TUBE HAS BEEN CUT AND DEPLOYED INTO THE BREAST BIOPSY SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8G MAMMOMARK BREAST MARKER FZP ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROL MODULE| HOLSTER