BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN

    MDR report key: 41056 · Received September 13, 1996

    Report

    Report Number
    41056
    Event Type
    Injury
    Date Received
    September 13, 1996
    Date of Event
    September 12, 1996
    Report Date
    September 13, 1996
    Manufacturer
    MCGHAN MED CORP.
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CAPSULAR CONTRACTURE. RIGHT BREAST. BREAST IMPLANT 11/30/93 HDH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN Implant BREAST IMPLANT FWM MCGHAN MED CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Required Intervention