BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR WORLDWIDE LLC

    MDR report key: 2805428 · Received November 2, 2010

    Report

    Report Number
    1645337-2010-00040
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    MENTOR WORLDWIDE LLC
    Product Code
    FWM
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE REPORT# 1645337-2010-00035 FOR DEVICE 1.

    Description of Event or Problem · 1

    SEPSIS INFECTION REQUIRING EMERGENCY AMBULANCE TRANSPORTATION AND HOSPITAL ADMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR WORLDWIDE LLC SALINE-FILLED MAMMARY PROSTHESES FWM MENTOR WORLDWIDE LLC 5799670

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other