BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASOUND

    MDR report key: 91237 · Received May 15, 1997

    Report

    Report Number
    MW1011318
    Event Type
    Injury
    Date Received
    May 15, 1997
    Date of Event
    September 2, 1993
    Report Date
    May 9, 1997
    Manufacturer
    UNK
    Product Code
    LXE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ON SEPT. 2. 1993 AN ULTRASOUND WAS ROUTINELY PERFORMED ON PT. WHO WAS 20 WKS PREGNANT. DURING THE ULTRASOUND THE TECH ZOOMED IN ON THE EYE. THE BABY LATER WENT BLIND IN ONE EYE DUE TO RUPTURE OF A SMALL BLOOD VESSELL IN THE EYE. THE TIME OF THE RUPTURE OF THE SMALL BLOOD VESSELL WAS SET AT ABOUT MIDWAY DURING THE PREGNANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASOUND FETAL ULTRASOUND LXE UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Disability