BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTOUR SYSTEM

    MDR report key: 47652 · Received September 10, 1996

    Report

    Report Number
    2424102-1996-90001
    Event Type
    Other
    Date Received
    September 10, 1996
    Date of Event
    August 15, 1996
    Report Date
    September 6, 1996
    Manufacturer
    BENNETT, SUBSIDIARY OF TREX MEDICAL CORP.
    Product Code
    IZH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ADMINISTRATOR MENTIONED THAT A PT WAS CLAIMING THAT HER BREAST IMPLANT WAS RUPTURED DURING A MAMMOGRAPHIC EXAM, USING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR SYSTEM MAMMOGRAPHIC X-RAY IZH BENNETT, SUBSIDIARY OF TREX MEDICAL CORP. M-1500G *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other