BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN

    MDR report key: 117679 · Received June 27, 1997

    Report

    Report Number
    117679
    Event Type
    Injury
    Date Received
    June 27, 1997
    Date of Event
    May 29, 1997
    Report Date
    June 2, 1997
    Manufacturer
    MCGHAN MEDICAL
    Product Code
    FWM
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEFLATED IMPLANT, RIGHT. BOTH REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN Implant BREAST IMPLANTS FWM MCGHAN MEDICAL STYLE 168 240CC KH5249 (RT)

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention