BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 9957531 · Received April 14, 2020

    Report

    Report Number
    9617229-2020-06937
    Event Type
    Injury
    Date Received
    April 14, 2020
    Date of Event
    March 30, 2019
    Report Date
    April 14, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO FDA REPORT NUMBER MW 5093399. THE EVENT OF "LYMPHADENOPATHY" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. NO CONTACT INFORMATION WAS PROVIDED FOR THE INITIAL REPORTER, THEREFORE ADDITIONAL EVENT, PRODUCT, AND/OR PATIENT DETAILS ARE NOT ATTAINABLE. REASON FOR REOPERATION: LYMPHADENOPATHY.

    Description of Event or Problem · 1

    PATIENT REPORTED VIA REGULATORY AGENCY ¿CONTINUED REDUCED HEALTH RELATED TO NATRELLE ALLERGAN BRAND BREAST IMPLANTS¿ AND ¿SWOLLEN AXIALLY LYMPH GLANDS¿. PATIENT ALSO REPORTED VIA REGULATORY AGENCY ¿DEVELOPED MULTIPLE AUTO IMMUNE DISORDERS¿; THIS IS NOT DEVICE RELATED. DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422908 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention