BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 24454910 · Received February 26, 2026

    Report

    Report Number
    9617229-2026-03639
    Event Type
    Injury
    Date Received
    February 26, 2026
    Report Date
    March 10, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO H10 RELATED REPORT NUMBERS: IT HAS BEEN IDENTIFIED THAT THIS RECORD, MRN 9617229-2026-03639, IS A DUPLICATE OF MRN 9617229-2019-23373 AND MRN 9617229-2026-03635. PLEASE SEE MRN 9617229-2019-23373 AND MRN 9617229-2026-03635 FOR REPORTABLE EVENTS.

    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: RUPTURE.

    Description of Event or Problem · 0

    IT HAS BEEN IDENTIFIED THAT THIS RECORD, MRN 9617229-2026-03639, IS A DUPLICATE OF MRN 9617229-2019-23373 AND MRN 9617229-2026-03635. PLEASE SEE MRN 9617229-2019-23373 AND MRN 9617229-2026-03635 FOR REPORTABLE EVENTS.

    Description of Event or Problem · 0

    PATIENT REPORTED THROUGH LEGAL REPRESENTATIVE "SILICONOMAS AT THE AXILLARY LEVEL AND RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340858 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention