BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO PMD150U

    MDR report key: 768222 · Received October 4, 2006

    Report

    Report Number
    3033518-2006-00001
    Event Type
    Injury
    Date Received
    October 4, 2006
    Date of Event
    August 10, 2006
    Report Date
    October 4, 2006
    Manufacturer
    SPENCER TECHNOLOGIES
    Product Code
    IYO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INITIAL INVESTIGATION, THE COMPANY HAS BEEN UNABLE TO FIND ANY INSTANCES OF A REPORTED COMPLAINT OR MEDICAL STUDY, LINKING THE USE OF DIAGNOSTIC ULTRASOUND TO SUDDEN ONSET REFRACTIVE CHANGES OR SUDDEN ONSET PRESBYOPIA IN THE EYE. WHILE THE INITIAL EVALUATION OF THE CLINICAL LITERATURE AND KNOWN RISKS OF MECHANICAL OR THERMAL DAMAGE ASSOCIATED WITH DIAGNOSTIC ULTRASOUND, LEADS US TO THE CONCLUSION THAT THE USE OF THE DEVICE WAS UNLIKELY TO HAVE CONTRIBUTED TO THE DESCRIBED INCIDENT. THE SYSTEM WILL BE EVALUATED WITHIN THE NEXT 60 DAYS TO DETERMINE IF THE DEVICE IS OPERATING WITHIN THE MANUFACTURING SPECIFICATION.

    Description of Event or Problem · 1

    APPROXIMATELY 6 DAYS AFTER VOLUNTARY PARTICIPATION IN A TRANSCRANIAL DOPPLER (TCD) DIAGNOSTIC ULTRASOUND EXAM A MALE HOSPITAL EMPLOYEE NOTIFIED THE HOSPITAL ABOUT HAVING HEADACHE & VISION PROBLEMS WHICH HE ATTRIBUTED TO THE EXAM. THE EMPLOYEE WAS SUBSEQUENTLY PRESCRIBED READING GLASSES. THE TECHNOLOGIST WAS NOT NOTIFIED BY THE EMPLOYEE OF ANY DISCOMFORT DURING OR IMMEDIATELY FOLLOWING THE EXAM. THE TECHNOLOGIST REPORTED ALL THE PROTOCOLS FOR PERFORMING THE TCD EXAM WERE FOLLOWED, ALL SYSTEM PERFORMANCE INDICATORS WERE NORMAL, AND THAT IT WAS UNLIKELY THE TCD EXAM CONTRIBUTED TO THE REPORTED EVENT. THE SYSTEM REMAINS IN NORMAL SERVICE AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PMD150U TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM IYO SPENCER TECHNOLOGIES PMD150 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Disability