BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JP RESERVOIR KIT; SILICONE FLAT DRAIN

    MDR report key: 314992 · Received February 6, 2001

    Report

    Report Number
    314992
    Event Type
    Injury
    Date Received
    February 6, 2001
    Date of Event
    November 24, 2000
    Report Date
    December 5, 2000
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Product Code
    GCY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT KIDNEY TRANSPLANT, AT WHICH TIME A JACKSON PRATT DRAIN WAS PLACED. WHEN THE PHYSICIAN REMOVED THE JP, A POPPING SOUND WAS HEARD. THE PT REQUIRED SURGICAL EXPLORATION FOR REMOVAL OF THE RETAINED FRAGMENT. THIS WAS NOTED TO BE 16 X 1.0 X 0.5 CM IN SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4507 JP RESERVOIR KIT; SILICONE FLAT DRAIN 10 MM JACKSON PRATT DRAIN GCY ALLEGIANCE HEALTHCARE CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization