BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 7086633 · Received December 6, 2017

    Report

    Report Number
    9617229-2017-04512
    Event Type
    Death
    Date Received
    December 6, 2017
    Date of Event
    March 29, 2010
    Report Date
    December 6, 2017
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CLARIFICATION: EVENTS OF LUMP/NODULE AND LYMPHOMA ARE KNOWN POTENTIAL ADVERSE EVENTS ADDRESSED IN BOTH SALINE AND SILICONE LABELING. AS IT IS UNKNOWN WHETHER THE AFFECTED DEVICE IS SALINE OR SILICONE, NO DEVICE LABELING CAN BE SENT AT THIS TIME. THE EVENTS OF LUMP/NODULE, LYMPHOMA AND DEATH ARE A PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    COMPANY REPRESENTATIVE REPORTED PATIENT HAD A MASS DISCOVERED ON (B)(6) 2010 AND BIOPSY PERFORMED ON (B)(6) 2010 WHICH CONFIRMED ALCL. AT THE TIME OF BIOPSY, ALCL HAD SPREAD INTO THE CHEST WALL. PATIENT WAS TREATED WITH CHEMOTHERAPY AND EXPLANT. PATIENT DIED IN "(B)(6) 2011" AFTER REMOVAL OF THE IMPLANT. AFFECTED SIDE UNKNOWN. AS NECESSARY PATHOLOGICAL MARKERS HAVE NOT BEEN CONFIRMED, THIS REPORT OF ALCL WILL BE CAPTURED AS LYMPHOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867930 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death| R