BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR

    MDR report key: 381818 · Received March 11, 2002

    Report

    Report Number
    381818
    Event Type
    Injury
    Date Received
    March 11, 2002
    Date of Event
    February 1, 2002
    Report Date
    February 1, 2002
    Manufacturer
    MENTOR
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ENTERS MEDICAL FACILITY TO UNDERGO BILATERAL EXPLANTATION OF CURRENT SALINE-FILLED SILTER IMPLANTS FROM MENTOR CORP AND REPLACEMENT OF A DEFLATED LEFT BREAST IMPLANT AND NON-DEFLATED RIGHT BREAST IMPLANT. THERE WAS NO TRAUMA TO IMPLANT PER PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR SALINE MAMMARY IMPLANTS FWM MENTOR UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R