BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TLS SURGICAL DRAINAGE SYSTEM

    MDR report key: 10760 · Received November 18, 1993

    Report

    Report Number
    10760
    Event Type
    Injury
    Date Received
    November 18, 1993
    Date of Event
    November 4, 1993
    Report Date
    November 5, 1993
    Manufacturer
    POREX SURGICAL, INC.
    Product Code
    GCY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRAIN TUBING SNAPPED IN HALF DURING DRESSING CHANGE AND BROKE OFF IN PT'S FOOT, NECESSITATING SURGERY TO REMOVE PIECE OF TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TLS SURGICAL DRAINAGE SYSTEM 10.5 FRENCH SILICONE DRAIN GCY POREX SURGICAL, INC. 054043

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R