BEUDAMED
    FDA Adverse Event Summary report: N

    FAST TROC

    MDR report key: 94932 · Received June 2, 1997

    Report

    Report Number
    MW1011382
    Date Received
    June 2, 1997
    Report Date
    March 11, 1997
    Manufacturer
    SENSORMEDICS CORP.
    Product Code
    KLK
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    SITE BURN FROM TRANSCUTANEOUS MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST TROC T-CATH KLK SENSORMEDICS CORP. FAST RAC *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 DAY