BEUDAMED
    FDA Adverse Event Death Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 3010202 · Received March 14, 2013

    Report

    Report Number
    2024601-2013-00141
    Event Type
    Death
    Date Received
    March 14, 2013
    Date of Event
    May 15, 2012
    Report Date
    September 4, 2012
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT LABELING FOR SALINE DEVICES PER (B)(4) STUDY: DEATH: 0%, INFECTION RATE FOR RECONSTRUCTION: 6%, SEPSIS 0%, DEFLATION RATE: 7.5%, CAPSULAR CONTRACTURE RATE: 35.7%.

    Description of Event or Problem · 1

    PATIENT'S FAMILY REPORTED DEATH DUE TO SEPSIS AFTER A POST-OPERATIVE INFECTION OCCURRED. THE PATIENT HAD A REVISION RECONSTRUCTION FOR BILATERAL DEFLATIONS AND GRADE IV CAPSULAR CONTRACTURES. WITHIN TWO WEEKS POST-OPERATIVELY, THE PATIENT HAD AN INFECTION ON THE LEFT BREAST WHICH WAS TREATED WITH ANTIBIOTICS BY THE SURGEON. THE PATIENT SUBSEQUENTLY DIED FROM SEPSIS. SEVERAL ATTEMPTS TO THE PHYSICIAN WERE MADE FOR FURTHER INFORMATION; NO RESPONSE OBTAINED OTHER THAN CONFIRMATION THAT THEY WERE ALSO AWARE OF THE PATIENT'S DEATH FROM SEPSIS. IF FURTHER INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED. THIS MEDWATCH REPORT IS SUBMITTED FOR THE PATIENT'S LEFT SIDE BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108144 STYLE 68 SALINE FILLED BREAST IMPLANT FWM ALLERGAN NA 1142914

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| R NO INFORMATION