BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 15113122 · Received July 27, 2022

    Report

    Report Number
    9617229-2022-13070
    Event Type
    Death
    Date Received
    July 27, 2022
    Report Date
    July 27, 2022
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OF DEATH IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. NO CONTACT INFORMATION WAS PROVIDED FOR THE INITIAL REPORTER, THEREFORE ADDITIONAL EVENT, PRODUCT, AND/OR PATIENT DETAILS ARE NOT ATTAINABLE. REASON FOR REOPERATION: "DEAD FROM SILICONE POISONING".

    Description of Event or Problem · 0

    PATIENT REPRESENTATIVE REPORTED VIA SOCIAL MEDIA POST "DEAD FROM SILICONE POISONING." THE MANUFACTURER OF THE DEVICE IS UNKNOWN. DEVICE STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033196 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR UNKNOWN MANUFACTURER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death