BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TLS SURGICAL DRAINAGE SYSTEM

    MDR report key: 172394 · Received June 11, 1998

    Report

    Report Number
    172394
    Event Type
    Injury
    Date Received
    June 11, 1998
    Date of Event
    June 3, 1998
    Report Date
    June 10, 1998
    Manufacturer
    PORTEX SURGICAL, INC.
    Product Code
    GCY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    21 YEAR OLD UNDERWENT SURGICAL REPAIR OF A RIGHT DISTAL RADIUS FRACTURE ON 6/2/1998. ON 6/3/1998, PHYSICIAN REMOVED THE DRAIN FROM THE RIGHT WRIST, AND THE DRAIN WAS NOT INTACT. A "STAT" X-RAY REVEALED A TUBULAR FOREIGN BODY. THE PT WAS RETURNED TO SURGERY ON 6/4/1998 FOR REMOVAL OF THE RETAINED PORTION OF THE DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TLS SURGICAL DRAINAGE SYSTEM 4MM FLAT SILICONE DRAIN GCY PORTEX SURGICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| R