BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 2210616 · Received August 10, 2011

    Report

    Report Number
    2024601-2011-00665
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    November 11, 2010
    Report Date
    November 22, 2010
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SUBMITTED ON (B)(6) 2011. DEVICE LABELING REVIEWED: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL, FOR PTS IN THE CORE STUDY, IN THE LABELING FOR SILICONE IMPLANTS. THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL FOR PTS IN THE (B)(4) STUDY INCLUDED IN THE LABELING FOR SALINE BREAST IMPLANTS.

    Description of Event or Problem · 1

    RECEIVED AN ABSTRACT ENTITLED, "PRIMARY ANAPLASTIC LARGE CELL LYMPHOMA OF THE BREAST OCCURRING IN PTS WITH SILICONE BREAST IMPLANTS", WAS REPORTED AND WILL BE PUBLISHED IN THE FINAL ARTICLE ENTITLED LEUKEMIA AND LYMPHOMA, AUG 2011;52(8):1481-1487. WITHIN THE ARTICLE, THIS PT IS IDENTIFIED AS PT 5. IT DOES NOT INDICATE IF SHE IS AN AUGMENTATION OR RECONSTRUCTION PT. THERE IS MINIMAL INFO PROVIDED IN THE ARTICLE REGARDING THIS PT. THE ONLY INFO THAT IS NOTED IS THAT THERE WAS A PATHOLOGY CONSULTATION ON TISSUE FROM THE FIBROUS CAPSULE OF THE RIGHT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM UNKNOWN MANUFACTURER NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other| R