BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 139197 · Received December 17, 1997

    Report

    Report Number
    139197
    Event Type
    Other
    Date Received
    December 17, 1997
    Report Date
    December 16, 1997
    Manufacturer
    UNK
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CAPSULAR CONTRACTURE AROUND BILATERAL BREAST IMPLANTS (SILICONE GEL), PARTIAL GEL BLEED FROM IMPLANTS. PT HAS PAIN ASSOCIATED WITH CONTRACTURES. PT HAS MYOFASCIAL SYNDROME WITH MULTIPLE PROBLEMS PRIMARILY INVOLVING LEFT TRAPEZIUS AND ARM. PT BELIEVES THIS TO BE RELATED TO HER GEL IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK Implant SILICONE GEL-FILLED BI-LUMEN MAMMARY PROSTHESIS FTR UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other