BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOW CORNING

    MDR report key: 66080 · Received December 27, 1996

    Report

    Report Number
    66080
    Event Type
    Injury
    Date Received
    December 27, 1996
    Date of Event
    November 11, 1996
    Report Date
    December 27, 1996
    Manufacturer
    DOW CORNING CORP. MDR REPORTING & COMPLAINT INVESTIGATION
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS RUPTURE OF RIGHT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOW CORNING Implant MAMMARY IMPLANT FTR DOW CORNING CORP. MDR REPORTING & COMPLAINT INVESTIGATION PO15-0450 HH046274

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization