BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, MAMMARY, INTERNAL

    MDR report key: 15538 · Received July 13, 1994

    Report

    Report Number
    15538
    Event Type
    Injury
    Date Received
    July 13, 1994
    Date of Event
    May 23, 1994
    Report Date
    June 3, 1994
    Manufacturer
    HEYER-SCHULTE CORP.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    S/P MAMMARY IMPLANTS WITH FAILURE OF PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Implant PROSTHESIS, MAMMARY, INTERNAL FTR HEYER-SCHULTE CORP. 156637 X 2

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention