BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON-ALLERGAN

    MDR report key: 22918942 · Received August 28, 2025

    Report

    Report Number
    9617229-2025-14743
    Event Type
    Injury
    Date Received
    August 28, 2025
    Report Date
    October 14, 2025
    Manufacturer
    NON-ALLERGAN
    Product Code
    FWM
    PMA / PMN Number
    -
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OF CAPSULAR CONTRACTURE 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 UNKNOWN.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A2, B5, D1, D3, D4, G1, G4. THE DEVICE ASSOCIATED WITH THIS COMPLAINT HAS BEEN CONFIRMED AS NON-ALLERGAN. THIS INFORMATION IS NO LONGER CONSIDERED REPORTABLE TO THE FDA.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    THE DEVICE ASSOCIATED WITH THIS COMPLAINT HAS BEEN CONFIRMED AS NON-ALLERGAN. THIS INFORMATION IS NO LONGER CONSIDERED REPORTABLE TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245987 NON-ALLERGAN PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM NON-ALLERGAN NI

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Female Required Intervention