BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 161822 · Received April 1, 1998

    Report

    Report Number
    MW1013470
    Event Type
    Malfunction
    Date Received
    April 1, 1998
    Date of Event
    March 19, 1998
    Report Date
    March 26, 1998
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MAMMARY IMPLANTS DEFLATED. THE LEFT ON 09/20/97 AND THE RIGHT ON 03/19/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant MAMMARY IMPLANT LEFT AND RIGHT FWM MCGHAN MEDICAL CORP. STYLE 168 *
    2 * Implant MAMMARY IMPLANT LEFT AND RIGHT FWM MCGHAN MEDICAL CORP. STYLE 168 *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other