BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHCEIN PREMIUM 30G SHORT NEEDLE

    MDR report key: 3242899 · Received July 19, 2013

    Report

    Report Number
    3002987375-2013-00001
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 19, 2013
    Manufacturer
    S.O.F.I.C. S.A.
    Product Code
    DZM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    SPONTANEOUS REPORT, LOCAL REFERENCE # (B)(4). INITIAL INFORMATION RECEIVED ON (B)(6) 2013. THE DENTIST REPORTED THAT ON (B)(6) 2013, SHE USED A SCHEIN PREMIUM 30G SHOT NEEDLE ON A (B)(6) YEAR OLD FEMALE PATIENT IN AN INFERIOR ALVEOLAR NERVE BLOCK. THE NEEDLE BROKE OFF IN THE PATIENT'S MOUTH AFTER THE PATIENT COUGHED. THEY WERE UNABLE TO RETRIEVE ALL THE PIECES SO THEY SENT THE PATIENT TO AN ORAL SURGEON TO HAVE IT REMOVED. THE PATIENT WAS SENT ON (B)(6) 2013, TO A DIFFERENT ORAL SURGEON TO SEE HOW THEY WERE GOING TO REMOVE IT. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 FROM FOLLOW UP WITH DENTIST. THE DENTIST REPORTED THAT FOLLOWING THE PATIENT'S VISITS TO THE 2 ORAL SURGEONS, ONE OF THE SURGEONS CONSULTED STATED THAT IT WAS DIFFICULT TO LOCATE THE BROKEN NEEDLE AND THEN SUGGESTED NOT TO ATTEMPT REMOVAL UNTIL AFTER SOME MONTHS TO PREVENT FURTHER DAMAGE AND INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339131 SHCEIN PREMIUM 30G SHORT NEEDLE DENTAL NEEDLE DZM S.O.F.I.C. S.A. F00127AA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Disability