BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC MAMMARY IMPLANT, ROUND, NFP

    MDR report key: 144235 · Received January 13, 1998

    Report

    Report Number
    1816403-1998-00020
    Event Type
    Injury
    Date Received
    January 13, 1998
    Date of Event
    January 1, 1981
    Report Date
    March 30, 1993
    Manufacturer
    DOW CORNING CORPORATION
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MEDICAL RECORDS SHOW PT HAD SURGICAL RELEASE OF HER RIGHT CAPSULAR SCAR ON 10/22/1981. PHYSICIAN'S NOTE STATES PT WAS HOSPITALIZED IN 1981 FOR A 2 1/2 MONTH PERIOD AND DIAGNOSED WITH APPARENT OSTEOMYELITIS. PHYSICIAN FELT THE OSTEOMYELITIS WAS DUE TO THE DRAINAGE OF PURULENT MATERIAL FROM THE AREOLAR COMPONENT OF THE RIGHT BREAST THREE WEEKS PRIOR TO HIS DIAGNOSIS. PT THEN DEVELOPED BAKER II-III IN THE LEFT BREAST WITH A "DOUBLE BUBBLE" EFFECT. OPERATIVE REPORT STATES PT HAD A HISTORY OF POLYARTHRALGIAS, MYALGIAS AND A DIFFUSE RASH ABOUT THE LEFT BREAST. UPON REMOVAL, THE RIGHT IMPLANT APPEARED TO BE INTACT AND ITS SHELL NORMAL. THE LEFT IMPLANT HAD SIGNIFICANT BLEED BUT WAS REMOVED INTACT. PT ALLEGES HAVING BONE PROBLEMS, JOINT PAIN, CHRONIC DEPRESSION AND ANXIETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC MAMMARY IMPLANT, ROUND, NFP Implant MAMMARY IMPLANT, GEL-FILLED FTR DOW CORNING CORPORATION NA H089579

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other| R