BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGHAN

    MDR report key: 150009 · Received February 17, 1998

    Report

    Report Number
    150009
    Event Type
    Malfunction
    Date Received
    February 17, 1998
    Date of Event
    February 10, 1998
    Report Date
    February 13, 1998
    Manufacturer
    MCGHAN MEDICAL
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS DEFLATIN OF THE LEFT BREAST IMPLANT REQUIRING REMOVAL AND REPLACMENT OF THE LEFT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN Implant SALINE BREAST IMPLANT FWM MCGHAN MEDICAL 168 HV3841

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other