BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 8878972 · Received August 9, 2019

    Report

    Report Number
    9617229-2019-10830
    Event Type
    Death
    Date Received
    August 9, 2019
    Report Date
    November 12, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO FDA REPORT NUMBER: MW5087744. 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. REASON FOR REOPERATION: LYMPHOMA. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Additional Manufacturer Narrative · 1

    THE EVENTS OF ALCL-LYMPHOMA AND LYMPHADENOPATHY ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

    Description of Event or Problem · 1

    REGULATORY AGENCY REPORTED CAUSE OF DEATH IS SEPSIS, MULTI ORGAN FAILURE DUE TO ALCL. UNKNOWN SIDE. UNKNOWN IF DEVICE WAS EXPLANTED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "PATIENT NOTICED A TUMOR INSIDE THE LEFT BREAST AND ALSO ENLARGED LYMPH NODES IN THE AXILLA. PATIENT ALSO NOTED B SYMPTOMS AND OVERLYING SKIN CHANGES. THE IMPLANTS WERE REMOVED AND ALCL COULD BE HISTOLOGICALLY CONFIRMED (CD30+, ALK-NEGATIVE". AFFECTED SIDE LEFT. DEVICE WAS EXPLANTED. "PATIENT ULTIMATELY TREATED WITH SURGICAL RESECTION, CHOP CHEMOTHERAPY, STEM CELL TRANSPLANT, BRENTUXIMAB, BUT PROGRESSED DESPITE THERAPY AND ULTIMATELY EXPIRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674489 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death| R