BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEYER SCHULTE

    MDR report key: 158254 · Received March 20, 1998

    Report

    Report Number
    MW1013338
    Event Type
    Injury
    Date Received
    March 20, 1998
    Report Date
    February 17, 1995
    Manufacturer
    HEYER SCHULTE/BAXTER HEALTHCARE CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RIGHT SALINE SHELL DEFLATED. A 63 YR OLD WHITE G1P1 FEMALE STATUS POST LEFT MODIFIED RADICAL MASTECTOMY AND RT SIMPLE MASTECTOMY IN 1976 FOR LOBULAR CANCER INSITU AND 1 YR LATER HAD BILATERAL SUBMUSCULAR RECONSTRUCTION W/ HEYER SCHULTE BILUMENS. THE RT HAD TO BE REMOVED FOR INFECTION AND WAS REPLACED IN 1977, IT WAS ALWAYS SMALLER AFTER THIS. CT MAMMOGRAM IN 1992 FOR COMPLAINTS OF LEFT SIDED CHEST PAIN, REVEALED LOSS OF SALINE. SURGERY 6/30/92 WAS POSITIVE FOR DEFLATED RT BILUMEN W/ MODERATE FIBROUS CAPSULES. NO HISTORY OF TRAUMA. EXAM POSITIVE FOR DECREASED SIZE W/ GRADE III CONTRACTURES ON RT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER SCHULTE Implant BILUMEN BREAST IMPLANTS FTR HEYER SCHULTE/BAXTER HEALTHCARE CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| S