BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENROSE

    MDR report key: 3113444 · Received April 29, 2013

    Report

    Report Number
    3113444
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BARD MEDICAL
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DURING THE STERILE SETUP, IT WAS NOTED THAT THE PENROSE DRAIN THAT HAD BEEN OPENED HAD A HAIR IN THE PACKAGE. THE DRAIN WAS REMOVED FROM THE STERILE FIELD, SET ASIDE, AND GIVEN TO THE NURSE MANAGER.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183259 PENROSE WOUND, DRAINAGE GCY BARD MEDICAL * NGWL1717

    Patients

    Seq Age Sex Outcome Treatment
    1 *