BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 468 SALINE FILLED BREAST IMPLANT

    MDR report key: 13771915 · Received March 15, 2022

    Report

    Report Number
    9617229-2022-01148
    Event Type
    Injury
    Date Received
    March 15, 2022
    Report Date
    March 15, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: "ONE BAG WAS BROKEN", "HAD EXTREME SHARP JABBING PAINS IN CHEST".

    Description of Event or Problem · 0

    PATIENT REPORTED FOR LEFT SIDE "HAS SYMPTOMS ON THE LEFT SIDE", "IT GOT FIBROTIC, GOT HARD, AND SOMETIMES EVERY 3 TO 6 MONTHS FEELS PAIN, IT¿S SO HEAVY AND IT PULLS ON THE GLAND¿, "ONE BAG WAS BROKEN", "EXTREME SHARP JABBING PAINS IN CHEST". ALSO REPORTED "RHEUMATOID ARTHRITIS AND SEVERE JOINT PAIN" WHICH IS NOT RELATED TO THE DEVICE. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615561 STYLE 468 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention