BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-SALINE MAMMARY IMPLANT

    MDR report key: 182391 · Received August 12, 1998

    Report

    Report Number
    2024601-1998-00169
    Event Type
    Injury
    Date Received
    August 12, 1998
    Report Date
    July 13, 1998
    Manufacturer
    MCGHAN MEDICAL CORPORATION
    Product Code
    FTR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGED PAIN. FOLLOW-UP FINDINGS: ALLEGED EVENT UNSUBSTANTIATED BY AN HEALTH PROFESSIONAL OUTCOME: UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEL-SALINE MAMMARY IMPLANT Implant GEL-SALINE MAMMARY IMPLANT FTR MCGHAN MEDICAL CORPORATION NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other