BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON-ALLERGAN

    MDR report key: 24500838 · Received March 3, 2026

    Report

    Report Number
    9617229-2026-03928
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    January 26, 2026
    Report Date
    March 3, 2026
    Manufacturer
    NON-ALLERGAN
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OF "_____" 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. REASON FOR REOPERATION: CAPSULAR CONTRACTURE, BAKER GRADE III/IV.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, D1, D3, D4, G1, H6.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED " SEVERE CAPSULAR CONTRACTURE BAKER GRADE III/IV ". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    THE DEVICE HAS BEEN CONFIRMED AS NON-ALLERGAN/ABBVIE AND THIS INFORMATION IS NO LONGER CONSIDERED REPORTABLE TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557495 NON-ALLERGAN PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM NON-ALLERGAN NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention