BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC MMRY VARIFIL 230CC

    MDR report key: 214606 · Received March 15, 1999

    Report

    Report Number
    1816403-1999-00107
    Event Type
    Injury
    Date Received
    March 15, 1999
    Date of Event
    February 24, 1989
    Report Date
    March 17, 1989
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THAT ON OR ABOUT FEBRUARY 24, 1989 THE PT NOTED HER RIGHT BREAST APPEARED TO BE SMALLER. REMOVAL SURGERY REVEALED A DEFLATED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC MMRY VARIFIL 230CC Implant MAM IMP SALINE-FILLED FTR DOW CORNING CORP. 225 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention