BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-TIP ANESTHESIA DELIVERY SYSTEM

    MDR report key: 2441135 · Received February 3, 2012

    Report

    Report Number
    2320721-2012-00003
    Event Type
    Injury
    Date Received
    February 3, 2012
    Report Date
    January 6, 2012
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    DZM
    PMA / PMN Number
    K990511
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT PHYSIOLOGICALLY POSSIBLE THAT INFECTION OF THE MAGNITUDE DESCRIBED WOULD HAVE DEVELOPED WITHIN THE ALLEGED TIME FRAME. RATHER, THE PT'S PRE-EXISTING STATE OF ORAL HEALTH RELATED TO THE SITE OF INJECTION MUST BE CLOSELY EVALUATED. HOWEVER, BECAUSE A SERIOUS INJURY RESULTED AFTER USE OF THE X-TIP, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT A PT DEVELOPED INFECTION WITHIN HOURS OF USE OF AN X-TIP. IT WAS REPORTED THAT THE SITE APPEARED "ALMOST LIKE INFECTION COMES OUT" AND THAT SWELLING DEVELOPED AFTER SEVERAL HOURS. THE PT WAS REFERRED TO AN ORAL SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-TIP ANESTHESIA DELIVERY SYSTEM DZM DENTSPLY TULSA DENTAL SPECIALTIES 111810001

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention