BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-SALINE MAMMARY IMPLANT

    MDR report key: 168396 · Received May 19, 1998

    Report

    Report Number
    2024601-1998-00111
    Event Type
    Injury
    Date Received
    May 19, 1998
    Date of Event
    February 21, 1994
    Report Date
    April 20, 1998
    Manufacturer
    GEL-SALINE MAMMARY IMPLANT
    Product Code
    FTR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ALLEGED MULTIPLE VARIED INJURIES. F/U FINDINGS: PER PHYSICIAN'S OFFICE, ALLEGED SYMPTOMS OF AUTOIMMUNE DISEASE AND PAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other