BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC GEL-SALINE MAMMARY IMPLANT

    MDR report key: 221232 · Received April 29, 1999

    Report

    Report Number
    1816403-1999-00178
    Event Type
    Injury
    Date Received
    April 29, 1999
    Report Date
    April 26, 1999
    Manufacturer
    DOW CORNING CORP
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    OPERATIVE REPORT OF 10/18/1994 STATES LEFT CAPSULECTOMY WITH EXCISION OF GRANULOMAS OF INFERIOR MEDIAL BREAST; REMOVAL OF RUPTURED GEL MATERIAL; REMOVAL OF PT'S RUPTURED LEFT BREAST IMPLANT; RIGHT CAPSULECTOMY; REMOVAL OF SCAR TISSUE AND THE RIGHT BREAST IMPLANT WAS REMOVED INTACT EXCEPT THE OUTER LUMEN DID NOT HAVE SALINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC GEL-SALINE MAMMARY IMPLANT Implant MAM IMP GEL-SALINE FTR DOW CORNING CORP UNK110 *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R