BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 2003941 · Received February 23, 2011

    Report

    Report Number
    MW5019559
    Event Type
    Other
    Date Received
    February 23, 2011
    Date of Event
    October 3, 2003
    Report Date
    February 23, 2011
    Manufacturer
    UNK
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ALCL CASE REPORT. THE PT HAD BREAST AUGMENTATION IN (B)(6) 2001. THE PT PRESENTED WITH A 4 CM MASS IN THE 6 O'CLOCK POSTERIOR POSITION IN THE LEFT BREAST ON (B)(6) 2003. THE PATHOLOGY WAS REVIEWED AS A CD30 POSITIVE T-CELL ALCL, ALK NEGATIVE. THE PT HAD LEFT BREAST IMPLANT REMOVED IN (B)(6) 2003. INITIAL THERAPY WAS CHOP BEGINNING IN (B)(6) 2003. AFTER AN INITIAL RESPONSE, SHE PROGRESSED AFTER 3 CYCLES. THE PT WAS THEN GIVEN DHAP THE LAST WEEK IN (B)(6) 2003 WITH A RESPONSE. IMMEDIATELY AFTER DHAP, SHE DEVELOPED AN INFECTION/ABSCESS IN THE LEFT BREAST. THE PT THEN HAD A LEFT TOTAL MASTECTOMY (B)(6) 2004. SHE EVENTUALLY COMPLETED 2 COURSES OF DHAP BY (B)(6) 2004. FOLLOWING PROGRESSION THE PT RECEIVED HYPER CVAD FOR ONE COURSE AT THE END OF (B)(6) WITH PROGRESSION IN (B)(6) 2004. THE PT THEN STARTED AN INVESTIGATIONAL THERAPY WITH SGN 30 FOR WHICH SHE ACHIEVED A COMPLETE REMISSION WHICH HAS BEEN SUSTAINED AT THIS TIME, THOUGH SHE DID HAVE XRT TO HER LEFT CHEST WALL IN (B)(6) 2004 AS A PREVENTATIVE METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN UNKNOWN FTR UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other