BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERICAN HEYER-SCHULTE

    MDR report key: 36012 · Received August 7, 1996

    Report

    Report Number
    36012
    Event Type
    Injury
    Date Received
    August 7, 1996
    Date of Event
    July 12, 1996
    Report Date
    July 22, 1996
    Manufacturer
    AMERICAN HEYER-SCHULTE CORP.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT WITH SEVERE FIBROCYSTIC BREAST DISEASE. ORIGINAL BILATERAL SUB-CUTANEOUS MASTECTOMIES WITH RECONSTRUCTION IN 6/80. CAPSULAR CONTRACTURES DEVELOPED WITH FURTHER SURGERY REQUIRED. 12/1/82 MAMMARY IMPLANTS REMOVED, FIBROUS CONTRACTURES RELEASED AND MUSCLE FLAPS RECONSTRUCTED WITH INSERT OF MAMMARY IMPLANTS. PT DEVELOPED PAIN AND TENDERNESS OF BREAST AREA WHICH WAS CONSTANT. OR PERFORMED. BILATERAL RUPTURE OF SHELL OF IMPLANT IDENTIFIED DURING OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN HEYER-SCHULTE Implant CUSTOM DESIGNED POLYURETHANE FOAM COVERED MAMMARY IMPLANT FTR AMERICAN HEYER-SCHULTE CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention