BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 664345 · Received January 9, 2006

    Report

    Report Number
    664345
    Event Type
    Other
    Date Received
    January 9, 2006
    Date of Event
    December 22, 2005
    Report Date
    December 28, 2005
    Manufacturer
    UNK
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BILATERAL CAPSULECTOMY WITH REMOVAL OF BILATERAL BREAST IMPLANTS (SILICONE GEL INNER AND SALINE OUTER) AND REPLACEMENT WITH BILATERAL SALINE BREAST IMPLANTS DUE TO BILATERAL CAPSULES AND RUPTURE. THE RIGHT CAPSULE WAS DESCRIBED AS GRADE II. THE RIGHT OUTER SALINE LUMEN WAS COMPLETELY DEPRESSED WITH SOME GEL BLEED AND MINIMAL GEL LEAKAGE. THE LEFT HAD AN INTRACAPSULAR RUPTURE WITH WHITE CHALKY OR CALCIFIC COATING OF THE CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SILICONE BREAST IMPLANT COMBO FTR UNK UNK UNK
    2 UNK SILICONE AND SALINE BREAST IMPLANT COMBO FTR UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other