BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN MEDICAL CORP

    MDR report key: 322461 · Received March 21, 2001

    Report

    Report Number
    322461
    Event Type
    Injury
    Date Received
    March 21, 2001
    Report Date
    March 19, 2001
    Manufacturer
    MCGHAN MEDICAL CORP
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RIGHT BREAST IMPLANT RUPTURED. LEFT BREAST IMPLANT WITH CAPSULAR CONTRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12368 MCGHAN MEDICAL CORP BILUMEN GEL/SALINE BREAST IMPLANT FTR MCGHAN MEDICAL CORP * *
    12369 MCGHAN MEDICAL CORP BILUMEN GEL/SALINE BREAST IMPLANT FTR MCGHAN MEDICAL CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| R