BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACK, ANAGIOGRAPHY

    MDR report key: 2522753 · Received March 29, 2012

    Report

    Report Number
    2522753
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Date of Event
    February 25, 2012
    Report Date
    March 27, 2012
    Manufacturer
    DEROYAL
    Product Code
    OEZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    DURING PERIPHERAL VASCULAR ANGIOGRAPHY, THE PHYSICIAN MADE A SKIN NICK WITH THE SCALPEL. AS HE MOVED THE BLADE TOWARD THE SCRUB TABLE WHILE SIMULTANEOUSLY PRESSING THE BUTTON TO RETRACT THE BLADE, THE SPRING IN BLADE SEEMED TO HAVE MALFUNCTIONED. INSTEAD OF RETRACTING, IT SHOT OUT WITH ENOUGH FORCE THAT IT LODGED IN THE WALL ABOUT 5-7 FEET FROM THE POINT OF DISCHARGE. NO INJURY NOTED TO THE PT OR HEALTHCARE WORKER. THE CUSTOMER SERVICE REPRESENTATIVE FILED A CUSTOMER COMPLAINT. TELL THE COMPANY TO CONTACT ME IF THEY WANT A SAMPLE FOR THE MANUFACTURER'S INVESTIGATION OF THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACK, ANAGIOGRAPHY PROCEDURE PACK OEZ DEROYAL * 24271355

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR NO OTHER THERAPIES