BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATTERSON 30G METAL HUB SHORT NEEDLE

    MDR report key: 485545 · Received September 26, 2003

    Report

    Report Number
    1412902-2003-00123
    Event Type
    Injury
    Date Received
    September 26, 2003
    Date of Event
    August 26, 2003
    Report Date
    September 2, 2003
    Manufacturer
    DENTSPLY MPL
    Product Code
    DZM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT WHILE INJECTING THE PATIENT THE NEEDLE BROKE OFF THE END OF THE SYRINGE IN THE PATIENT'S GUM. THE PATIENT WAS REFERRED TO THE EMERGENCY ROOM WHERE THE ORAL SURGEON ELECTED TO SEDATE THE PATIENT AND TRIED UNSUCCESSFULLY TO REMOVE THE NEEDLE. A CT SCAN WAS PERFORMED THE NEXT DAY TO DETERMINE THE LOCATION OF THE NEEDLE AND THE DOCTOR SUCCESSFULLY REMOVED IT. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A VERY SORE THROAT AND THEIR DIABETES WAS NOT WELL CONTROLLED AFTER THE PROCEDURE. THE PATIENT REMAINED HOSPITALIZED ONE DAY AFTER THE REMOVAL OF THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATTERSON 30G METAL HUB SHORT NEEDLE DENTAL NEEDLE DZM DENTSPLY MPL NA 9024

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R