BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSMETIC AUGMENTATION

    MDR report key: 146656 · Received December 31, 1997

    Report

    Report Number
    146656
    Event Type
    Injury
    Date Received
    December 31, 1997
    Date of Event
    July 24, 1997
    Report Date
    July 24, 1997
    Manufacturer
    DOW CORNING CORP./MDR REPORTING & COMPLAINT INVESTIGATION
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF BILATERAL SILICONE BREAST IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSMETIC AUGMENTATION Implant BREAST IMPLANTS FTR DOW CORNING CORP./MDR REPORTING & COMPLAINT INVESTIGATION * HH086390

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention