BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SALINE IMPLANT

    MDR report key: 12004591 · Received June 15, 2021

    Report

    Report Number
    9617229-2021-07302
    Event Type
    Injury
    Date Received
    June 15, 2021
    Report Date
    June 15, 2021
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OF "CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN 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.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED ABOUT AN UNKNOWN SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901234 UNK SALINE IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention