BEUDAMED
    FDA Adverse Event Injury Summary report: N

    200915-STAMP PLATFORM/115V

    MDR report key: 479329 · Received August 22, 2003

    Report

    Report Number
    1222791-2003-00012
    Event Type
    Injury
    Date Received
    August 22, 2003
    Date of Event
    August 12, 2003
    Report Date
    August 21, 2003
    Manufacturer
    0700-C.R.BARD ELECTROPHYSIOLOGY PRODUCT
    Product Code
    DRQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PT RECEIVED A BURN ON THE RIGHT LEG DURING THE PROCEDURE FROM THIS DEVICE. THE PT'S CONDITION IS UNK AND THE SAMPLE IS BEING RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 200915-STAMP PLATFORM/115V 126010065-LABSYSTEMS DRQ 0700-C.R.BARD ELECTROPHYSIOLOGY PRODUCT NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention