BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK SALINE IMPLANT

    MDR report key: 9310381 · Received November 12, 2019

    Report

    Report Number
    9617229-2019-18132
    Event Type
    Death
    Date Received
    November 12, 2019
    Date of Event
    June 15, 2019
    Report Date
    April 2, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D.1., D.2., D.4., G.5.

    Additional Manufacturer Narrative · 0

    THE EVENT OF SEROMA IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "DIAGNOSED WITH BIA-ALCL" AND DEATH. DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR UNKNOWN SIDE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED ¿RIGHT SIDE SWELLING AND FULLNESS,¿ AND ADDITIONALLY NOTED ¿RIGHT BREAST WAS VERY TIGHT.¿

    Additional Manufacturer Narrative · 1

    THE EVENT OF LYMPHOMA-ALCL-SUSPECTED IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE REASON FOR REOPERATION: "BIA-ALCL." FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THESE ARE KNOWN POTENTIAL ADVERSE EVENTS ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED "DIAGNOSED WITH BIA-ALCL" AND DEATH. DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR UNKNOWN SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105980 UNK SALINE IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death| R