BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASYS

    MDR report key: 489082 · Received September 25, 2003

    Report

    Report Number
    MW1029682
    Event Type
    Malfunction
    Date Received
    September 25, 2003
    Date of Event
    September 19, 2003
    Report Date
    September 25, 2003
    Manufacturer
    ADAC LABORATORIES
    Product Code
    KPW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    COLLIMATOR EXCHANGE CARRIER WAS OUT OF ADJUSTMENT. FELL ON EMPLOYEE CAUSING STRAIN TO BACK AND INJURY TO HIP AND RIGHT FOOT. FIELD REP NOTIFIED. ON-SITE VISIT CONDUCTED OF EQUIPMENT. EXCHANGE CARRIAGE WAS OUT OF ADJUSTMENT. ADJUSTED CARRIER AND CLEANED BEARINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEGASYS COLLIMATOR EXCHANGER CARRIER KPW ADAC LABORATORIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other