BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 15971000 · Received December 13, 2022

    Report

    Report Number
    9617229-2022-22831
    Event Type
    Injury
    Date Received
    December 13, 2022
    Report Date
    December 13, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD IS NOT AVAILABLE DUE TO INSUFFICIENT DEVICE DATA. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE I.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED ¿ INTRACAPSULAR DAMAGE OF SMOOTH BREAST IMPLANT.¿ AND HEALTHCARE PROFESSIONAL ALSO REPORTED " THE PATIENT WAS CLASSIFIED AS CLASS 1 BY THE BAKER CLASSIFICATION " THIS IS FOR A UNKNOWN SIDE. THE DEVICE STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2181390 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention