BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEYER-SCHULTE CORP.

    MDR report key: 87252 · Received April 23, 1997

    Report

    Report Number
    87252
    Event Type
    Injury
    Date Received
    April 23, 1997
    Date of Event
    April 22, 1997
    Report Date
    April 22, 1997
    Manufacturer
    HEYER-SCHULTE CORP.
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BILATERAL CAPSULAR CONTRACTURES. LEAKAGE OF RIGHT SALINE IMPLANT. BREAST LUMP ON LEFT. ELECTIVE REPLACEMENT LEFT BREAST IMPLANT. REPLACEMENT DUE TO LEAKAGE, DEFLATION, RIGHT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE CORP. Implant MAMMARY PROSTHESIS FWM HEYER-SCHULTE CORP. 1600 ROUND 225CC *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention