BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC MAMMARY PROSTHESIS

    MDR report key: 165592 · Received May 1, 1998

    Report

    Report Number
    1816403-1998-00183
    Event Type
    Injury
    Date Received
    May 1, 1998
    Report Date
    February 28, 1995
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MED WATCH REPORT #1013319. INFORMATION PROVIDED WAS ILLEGIBLE AND THEREFORE IT WAS DIFFICULT TO DECIPHER EVENTS AND PROBLEMS. PLEASE NOTE THE REPORTER SENT IN ANOTHER FORM LISTING INJURIES AND THEY MENTION THE PT HAD BREAST IMPLANTS IN 1972, YET THEY LIST THE IMPLANT DATE AS 05/29/70. THERE IS NO INDICATION THAT THERE WERE TWO SETS OF IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC MAMMARY PROSTHESIS Implant MAMMARY IMPLANT, GEL-FILLED FTR DOW CORNING CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| R| S