BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18 FR. INTRODUCER/ SHEATH

    MDR report key: 1901938 · Received November 14, 2010

    Report

    Report Number
    1901938
    Event Type
    Malfunction
    Date Received
    November 14, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 14, 2010
    Manufacturer
    COOK
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON REMOVING STERILE SHEATH FROM MANUFACTURER PACKAGING, THE SHEATH WAS FOUND TO HAVE BLACK RESIDUE ON PRODUCT DURING PREPARATION FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 18 FR. INTRODUCER/ SHEATH 18 FR. INTRODUCER/ SHEATH DYB COOK NA 2530024

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR