BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 23780662 · Received December 11, 2025

    Report

    Report Number
    9617229-2025-21600
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    January 1, 2019
    Report Date
    March 2, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    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 III.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5.

    Description of Event or Problem · 0

    PATIENT REPORTED THROUGH REGULATORY AGENCY "RECALL", "PAIN", "HARDENED", "CHANGES IN BREAST SHAPE" AND "CAPSULAR CONTRACTURE BAKER GRADE III", "DISCOMFORT", "VISIBLE DEFORMITY" AND "LIMITATION IN DAILY ACTIVITIES". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED. IT IS UNKNOWN IF DEVICE WILL BE RETURNED.

    Description of Event or Problem · 0

    PREVIOUS MEDWATCH SUBMISSION NOTED CAPSULAR CONTRACTURE BAKER GRADE III. UPON FURTHER INFORMATION, ALLERGAN HAS DETERMINED THAT THIS RECORD IS A DUPLICATE RECORD. PLEASE SEE CN-130935 AS THE OPERATING RECORD RELATED TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299088 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Unknown Required Intervention