BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO PACK

    MDR report key: 1900974 · Received November 11, 2010

    Report

    Report Number
    MW5018199
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 11, 2010
    Manufacturer
    DEROYAL
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS FOUND, IN A STERILE ANGIOGRAPHY PACK, PART OF AN INSECT IN A 4 X 4 SPONGE. DIAGNOSIS OR REASON FOR USE: R/O CAD. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO PACK 4X4 SPONGE GDY DEROYAL 89-4719.01 22922073

    Patients

    Seq Age Sex Outcome Treatment
    1