BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INPECO SYSTEM

    MDR report key: 838742 · Received April 13, 2007

    Report

    Report Number
    1628664-2007-00030
    Event Type
    Injury
    Date Received
    April 13, 2007
    Date of Event
    January 22, 2007
    Report Date
    January 22, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JQW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE OF THE OPERATORS OF THE ABBOTT ACCELERATOR APS (INPECO SYSTEM) HAD LIFTED THE PERSPEX HOOD IN ORDER TO RETRIEVE A SAMPLE TUBE THAT HAD FALLEN FROM THE SAMPLE ARM ONTO THE CONVEYOR TRACK. WHILE IN THE PROCESS OF RETRIEVING THE SAMPLE TUBE, THE HOOD FELL BACK ONTO THE OPERATOR'S HEAD. THE OPERATOR WAS SEEN BY THE HOSPITALS CASUALTY DEPARTMENT AND HAS HAD SEVERAL FOLLOW-UP APPOINTMENTS WITH HER PERSONAL PHYSICIAN AND THE HOSPITAL'S OCCUPATIONAL HEALTH DEPARTMENT. THE OPERATOR WAS ON MEDICAL LEAVE FOR SIX WEEKS FOLLOWING THE EVENT. THE HOSPITAL ALSO REPORTED THE EVENT TO THE FACILITY OF ANOTHER COUNTRY, UNDER THE REPORTING OF INJURIES, DISEASES AND DANGEROUS OCCURRENCES REGULATIONS, 1995 (RIDDOR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INPECO SYSTEM AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM JQW ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other