BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE68 - LOW PROFILE

    MDR report key: 214233 · Received March 11, 1999

    Report

    Report Number
    214233
    Event Type
    Injury
    Date Received
    March 11, 1999
    Date of Event
    March 4, 1999
    Report Date
    March 10, 1999
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FWN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    01/19/99: BILATERAL SALINE MAMMARY IMPLANTS SURGICALLY PLACED. THE LEFT BREAST IMPLANT SLOWLY BUT PROGRESSIVELY LOST VOLUME UNTIL IT WAS OBVIOUS THAT THE IMPLANT WAS FAILING. 03/04/99: FAILED LEFT MAMMARY IMPLANT WAS EXPLANTED. IDENTICAL REPLACEMENT WAS INSERTED. PATHOLOGY EVALUATION OF DEVICE REVEALED A PARTIALLY COLLAPSED SILASTIC BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STYLE68 - LOW PROFILE Implant MAMMARY IMPLANT FWN MCGHAN MEDICAL CORP. 2568151 LEFT 3426

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention