BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMMOSTAR REVOLVE BIOPSY SITE IDENTIFIER, 8GA

    MDR report key: 3170067 · Received May 8, 2013

    Report

    Report Number
    2134494-2013-00001
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 9, 2013
    Manufacturer
    CARBON MEDICAL TECHNOLOGIES, INC.
    Product Code
    NEU
    PMA / PMN Number
    K100994
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT REMAINS IMPLANTED. THE DEVICE WAS NOT RETURNED FOR INSPECTION AND ANALYSIS; THEREFORE, NO DEFINITIVE CONCLUSION CAN BE DRAWN. THE ASSOCIATED DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND, SPECIFICALLY PACKAGING AND STERILIZATION RECORDS. BIOCOMPATIBILITY TESTING HAS BEEN CONDUCTED AND HAS DEMONSTRATED THAT THE DEVICE IS NON-IRRITATING AND NON-SENSITIZING.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE RADIOLOGIST THAT AFTER A BREAST BIOPSY PROCEDURE USING THE MAMMOTOME REVOLVE PROBE/SYSTEM, A PATIENT DEVELOPED A REDNESS AT THE INCISIONAL SITE. THE PATIENT HAD A 4CM CIRCLE OF REDNESS THAT WAS HOT AND TENDER TO TOUCH TWO DAYS POST PROCEDURE. AN ANTIBIOTIC WAS PRESCRIBED. AFTER TWO DAYS OF ANTIBIOTICS THE PATIENT STILL HAD A REDDISH/PINKISH CIRCULAR AREA AROUND THE INCISION. THE RADIOLOGIST NOW THINKS THAT IT IS A REACTION FROM WITHIN THE BREAST BECAUSE THE ANTIBIOTIC DID NOT COMPLETELY RESOLVE THE REDNESS WITHIN TWO DAYS AS EXPECTED. THE RADIOLOGIST LAST REPORTED THAT THE REACTION IS RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202576 MAMMOSTAR REVOLVE BIOPSY SITE IDENTIFIER, 8GA MARKER, RADIOGRAPHIC, IMPLANTABLE NEU CARBON MEDICAL TECHNOLOGIES, INC. 1211318A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BIOPSY PROBE GUIDE: MG08A| BIOPSY PROBE: MST0809