BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAIN, SUCTION, 15FR, ROUND

    MDR report key: 231359 · Received June 24, 1999

    Report

    Report Number
    1423507-1999-00174
    Event Type
    Malfunction
    Date Received
    June 24, 1999
    Date of Event
    April 29, 1999
    Report Date
    May 25, 1999
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Product Code
    JCY
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    ACCOUNT STATES A 58YR OLD DEVELOPED AN INFECTION AND REQUIRED RE-ADMISSION AND SURGERY FOR REMOVAL OF A RETAINED PORTION OF A JACKSON-PRATT DRAIN. INITIAL ABDOMINAL SURGERY WITH INSERTION OF THE DRAIN WAS 1999. DRAIN INITIALLY REMOVED IN PHYSICIANS OFFICE AFTER PT WAS DISCHARGED. PHYSICIAN UNAWARE THAT A PORTION OF THE DRAIN HAD BROKEN OFF AND REMAINED IN THE PT. PT DEVELOPED AN ABDOMINAL WALL INFECTION WHICH PROMPTED EXPLORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAIN, SUCTION, 15FR, ROUND WOUND DRAIN JCY ALLEGIANCE HEALTHCARE CORP. SU130-1323 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR