BEUDAMED
    FDA Adverse Event Death Summary report: N

    STYLE 363 SALINE FILLED BREAST IMPLANT

    MDR report key: 8010708 · Received October 26, 2018

    Report

    Report Number
    9617229-2018-08412
    Event Type
    Death
    Date Received
    October 26, 2018
    Report Date
    February 7, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION CONTAINED IN THIS REPORT WAS PREVIOUSLY SUBMITTED UNDER MW: 9617229-2019-09971, HOWEVER THIS WAS FOUND TO BE A DUPLICATE OF THIS MW: 9617229-2018-08412.

    Description of Event or Problem · 0

    ADDITIONALLY, REGULATORY AGENCY REPORTED ¿[PATIENT] NOTED A CHANGE OF RIGHT RECONSTRUCTED BREAST IN (B)(6) 2018. [PATIENT] COMPLAINED OF PAIN AND FELT THE IMPLANT HAD SHIFTED. CT SCAN REVEALED PRESENCE OF RIGHT SIDED 9 CM MASS OF THE ANTERIOR CHEST WALL WITH MEDIASTINAL, PLEURAL AND CHEST WALL SPREAD. UPON DIAGNOSIS OF ALCL, [PATIENT] WAS REFERRED TO THE HEME-ONCOLOGY SERVICE AND [PATIENT] WAS TREATED WITH CEOP CHEMOTHERAPY. IT WAS BEING CONSIDERED BY THE ONCOLOGY TEAM THAT [PATIENT] UNDERGO TREATMENT WITH RITUXIMAB AS [PATIENT] DISEASE WAS PROGRESSING WHEN DUE TO RECURRENT SEPSIS, THE PATIENT ELECTED TO RECEIVE PALLIATIVE CARE. [PATIENT] DIED ON (B)(6) 2019.¿ THIS RECORD IS FOR THE RIGHT SIDE.

    Additional Manufacturer Narrative · 1

    CLARIFICATION: THIS EVENT IS A KNOWN POTENTIAL ADVERSE EVENT 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 EVENT OF LYMPHOMA IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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

    HEALTH PROFESSIONAL REPORTED EVENT OF UNSPECIFIED SIDE "POTENTIAL ALCL PATIENT (OLD MEGHAN IMPLANT) WITH POSITIVE CD30." DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850377 STYLE 363 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| R