BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLID NASAL IMPLANT

    MDR report key: 37002 · Received September 3, 1996

    Report

    Report Number
    2024601-1996-02454
    Event Type
    Injury
    Date Received
    September 3, 1996
    Date of Event
    January 4, 1996
    Report Date
    August 6, 1996
    Manufacturer
    MCGHAN MED CORP
    Product Code
    FZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PT'S NAME IN "E1" SECTION IS NOT PROVIDED TO MAINTAIN CONFIDENTIALITY. DEVICE EVAL METHOD CODE 86= DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ALLEGED EROSION. FOLLOW-UP FINDINGS: INFECTION OF UNK ETIOLOGY WITH EXTRUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLID NASAL IMPLANT Implant SOLID NASAL IMPLANT FZE MCGHAN MED CORP FACIAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention