BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 24874485 · Received April 14, 2026

    Report

    Report Number
    9617229-2026-06764
    Event Type
    Injury
    Date Received
    April 14, 2026
    Report Date
    April 29, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    CLARIFICATION TO H10 RELATED REPORT NUMBERS: IT HAS BEEN IDENTIFIED THAT THIS RECORD, MRN 9617229-2026-06764, IS A DUPLICATE OF MRN 9617229-2025-17702 & MRN 9617229-2025-17520. PLEASE SEE MRN 9617229-2025-17702 & MRN 9617229-2025-17520 FOR REPORTABLE EVENTS.

    Description of Event or Problem · 0

    SALES REPRESENTATIVE REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR AN UNKNOWN SIDE. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    IT HAS BEEN IDENTIFIED THAT THIS RECORD, MRN 9617229-2026-06764, IS A DUPLICATE OF MRN 9617229-2025-17702 & MRN 9617229-2025-17520. PLEASE SEE MRN 9617229-2025-17702 & MRN 9617229-2025-17520 FOR REPORTABLE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107808 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention