BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK SALINE IMPLANT

    MDR report key: 3052203 · Received April 5, 2013

    Report

    Report Number
    2024601-2013-00277
    Event Type
    Death
    Date Received
    April 5, 2013
    Date of Event
    January 1, 2012
    Report Date
    March 25, 2013
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT ON (B)(4) 2013. SALINE DEVICE LABELING (IN FOUR MAJOR STUDIES) IS AS FOLLOWS: DEATH: NO EVENTS REPORTED. LUPUS, FIBROMYALGIA: (B)(4); LUNG DISEASE: (B)(4). DEVICE LABELING STATES THE FOLLOWING: "A REVIEW OF SEVERAL LARGE EPIDEMIOLOGICAL STUDIES OF WOMEN WITH AND WITHOUT IMPLANTS INDICATES THAT THESE DISEASES ARE NO MORE COMMON IN WOMEN WITH IMPLANTS THAN WOMEN WITHOUT IMPLANTS."

    Description of Event or Problem · 1

    PT'S HUSBAND REPORTED THE FOLLOWING ADVERSE EVENTS TO THE FDA VIA MEDWATCH REPORT: DEATH, LUPUS, FIBROMYALGIA, LUNG DISEASE, AND RESPIRATORY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141930 UNK SALINE IMPLANT FWM ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death