BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA SAFETY PLUS XL (27 GAUGE LONG)

    MDR report key: 2542535 · Received April 13, 2012

    Report

    Report Number
    9610964-2012-00001
    Event Type
    Injury
    Date Received
    April 13, 2012
    Report Date
    March 27, 2012
    Manufacturer
    SEPTODONT SAS
    Product Code
    EJI
    PMA / PMN Number
    K945843
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    (B)(4). INITIAL INFORMATION RECEIVED ON (B)(6) 2012. THE DENTIST REPORTED THAT A PATIENT (UNSPECIFIED GENDER), WITH NO SPECIFIC MEDICAL HISTORY, HAD BEEN TREATED WITH ULTRA SAFETY PLUS XL 27G LONG 0.40X35MM STERILE INJECTABLE SYSTEM WITH PROTECTIVE SHEATH AND HANDLE. ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED DEVICE FAILURE. THE DEVICE SEPARATED. THE CANNULA STAYED IN THE PATIENT'S MOUTH AND WAS REMOVED BY SURGERY. ACCORDING TO THE DENTIST, THE CANNULA DID NOT BREAK; IT BECAME DISCONNECTED FROM THE HUB. THE PATIENT HAD FULLY RECOVERED ON AN UNSPECIFIED DATE. NO OTHER INFORMATION IS AVAILABLE. THIS CASE REPORT IS CONSIDERED SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA SAFETY PLUS XL (27 GAUGE LONG) CARTRIDGE SYRINGE EJI SEPTODONT SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention