BEUDAMED
    FDA Adverse Event Injury Summary report: N

    225 CC H/S GEL FILLED

    MDR report key: 69247 · Received February 14, 1997

    Report

    Report Number
    1645337-1996-00100
    Event Type
    Injury
    Date Received
    February 14, 1997
    Date of Event
    August 16, 1990
    Report Date
    February 13, 1997
    Manufacturer
    MENTOR H/S
    Product Code
    FTR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PURSUANT TO INFO RECEIVED FROM THE PHYSICIAN, THE PT WAS IMPLANTED BILATERALLY WITH COMBINATION GEL/SALINE MAMMARY PROSTHESIS ON 8/24/88. SUBSEQUENTLY, IT WAS NOTED THAT THE PT HAD DEVELOPED AUTO-IMMUNE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 225 CC H/S GEL FILLED Implant * FTR MENTOR H/S NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention