BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JACKSON-PRATT

    MDR report key: 231356 · Received June 24, 1999

    Report

    Report Number
    231356
    Event Type
    Injury
    Date Received
    June 24, 1999
    Date of Event
    April 29, 1999
    Report Date
    May 13, 1999
    Manufacturer
    ALLEGIANCE HEALTH CARE
    Product Code
    JCY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    58 Y/O DEVELOPED INFECTION & REQUIRED RE-ADMISSION & SURGERY FOR REMOVAL OF A RETAINED PORTION OF A JACKSON-PRATT DRAIN. INITIAL ABDOMINAL SURGERY WITH INSERTION OF DRAIN WAS DONE 1999. DRAIN INITIALLY REMOVED IN PHYSICIAN'S 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 THE EXPLORATION WHICH OCCURRED 4/29/99.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JACKSON-PRATT SILICONE ROUND DRAIN W/RADIOPAQUE STRIPPED JCY ALLEGIANCE HEALTH CARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention