BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA 4100-IQ

    MDR report key: 3775320 · Received April 16, 2014

    Report

    Report Number
    9611343-2014-00061
    Event Type
    Injury
    Date Received
    April 16, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN CUT HIS HAND ON A SHARP PIECE OF METAL WHILE TRYING TO MOVE THE LEAD SHIELD INSTALLED WITH AN INNOVA 4100-IQ VASCULAR SYSTEM. HE WENT TO THE EMERGENCY DEPARTMENT AND REFUSED STITCHES AND OPTED FOR DERMABOND. THE DERMABOND TO HIS INDEX FINGER DID NOT HOLD AND HE RETURNED TO THE EMERGENCY DEPARTMENT FOR AN ADD'L APPLICATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233801 INNOVA 4100-IQ INTERVENTIONAL FLUOROSCOPIC X-RAY OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other