BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEYER-SCHULTE

    MDR report key: 148024 · Received January 9, 1998

    Report

    Report Number
    148024
    Event Type
    Injury
    Date Received
    January 9, 1998
    Date of Event
    October 21, 1997
    Report Date
    December 31, 1997
    Manufacturer
    HEYER-SCHULTE CORP. DIV. OF AMERICAN HOSP. SUPPLY
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT FOR SURGERY FOR CAPSULAR CONTRACTURES. NOTED IMPLANTS RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE Implant MAMMARY IMPLANTS VOL 275 CC FTR HEYER-SCHULTE CORP. DIV. OF AMERICAN HOSP. SUPPLY STYLE 6000 212181

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization