BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIDOCAINE 1% 5MIL

    MDR report key: 733026 · Received July 10, 2006

    Report

    Report Number
    2023988-2006-00027
    Event Type
    Malfunction
    Date Received
    July 10, 2006
    Report Date
    July 6, 2006
    Manufacturer
    HOSPIRA WORLDWIDE LAC
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A REP FROM THE PHYSICIAN'S OFFICE ADVISED THAT SEVERAL PTS REPORTED A BURNING SENSATION DURING THE LIDOCAINE INJECTION. THE REP HAD AN INJECTION HERSELF AND CONFIRMED THE BURNING SENSATION. THE REP FURTHER REPORTED NEVER HAVING THAT REACTION TO LIDOCAINE IN THE PAST. THIS MEDICAL DEVICE IS LINKED WITH MEDICAL DEVICE REPORT #?S: 2023988-2006-00025; 2023988-2006-00027; 2023988-2006-00028 AND 2023988-2006-00029.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIDOCAINE 1% 5MIL KIT COMPONENTS KSZ HOSPIRA WORLDWIDE LAC * 009445

    Patients

    Seq Age Sex Outcome Treatment
    1 *