BEUDAMED
    FDA Adverse Event Death Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 5061124 · Received September 8, 2015

    Report

    Report Number
    9617229-2015-00318
    Event Type
    Death
    Date Received
    September 8, 2015
    Date of Event
    March 8, 2010
    Report Date
    March 8, 2010
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLINICAL RESEARCH ORGANIZATION REPORTED PATIENT'S DEATH DUE TO "NDI -J189- PNEUMONIA, UNSPECIFIED" WHICH WAS RECEIVED VIA A "LEXIS NEXIS SEARCH." FOLLOW-UP WITH THE PHYSICIAN'S OFFICE AND PATIENT'S LISTED CONTACT PERSON DID NOT RETURN ANY INFORMATION. CAUSALITY OF THE EVENTS REMAIN UNKNOWN. SIDE UNSPECIFIED. THIS MEDWATCH IS FOR THE RIGHT SIDE. SEE MFR # 9617229-2015-00319 FOR THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593143 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1692941

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death