BEUDAMED
    FDA Adverse Event Other Summary report: N

    JP HEMADUCT 19FR W/15FR TROCAR

    MDR report key: 1671179 · Received April 22, 2010

    Report

    Report Number
    1423507-2010-00022
    Event Type
    Other
    Date Received
    April 22, 2010
    Date of Event
    December 3, 2009
    Report Date
    April 22, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GBX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THERE WAS A TINY FRACTURE ON THE DRAIN SO FLUID COULD NOT BE DRAINED. REPORTEDLY, A SUTURE WAS USED TO SECURE THE DRAIN TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JP HEMADUCT 19FR W/15FR TROCAR WOUND DRAIN GBX CARDINAL HEALTH JP-HUR195 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention