BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8G MAMMOMARK BREAST MARKER

    MDR report key: 1153299 · Received September 8, 2008

    Report

    Report Number
    3005075853-2008-01588
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 14, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    FZP
    PMA / PMN Number
    K003777
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. 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 INFORMATION 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, AFTER REMOVING THE MARKER, THE PHYSICIAN NOTICED THAT THE PLASTIC TIP HAD SHEARED OFF. THE PHYSICIAN TOOK SEVERAL ADDITIONAL CORES AND WAS ABLE TO REMOVE SOME OF THE PLASTIC TIP BUT SHE WAS UNSURE IF SHE REMOVED ALL OF IT. PATIENT WAS SENT HOME UNDER NORMAL POST BIOPSY INSTRUCTIONS.

    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 Other CONTROL MODULE| HOLSTER