BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JACKSON PRATT 10MM FLAT DRAIN FULL PERF

    MDR report key: 1022723 · Received March 27, 2008

    Report

    Report Number
    1423507-2008-00031
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    November 28, 2007
    Report Date
    March 26, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO HAS BEEN FORWARDED TO THE MANUFACTURING FACILITY. RESULTS OF INVESTIGATION PENDING. A FOLLOW-UP MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DRAIN BROKE WHEN BEING REMOVED FROM THE PT. A SURGICAL PROCEDURE WAS REQUIRED FOR REMOVAL OF THE REST OF THE BROKEN DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JACKSON PRATT 10MM FLAT DRAIN FULL PERF WOUND DRAIN GCY CARDINAL HEALTH SU130-1311 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention