BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN INTERN. 27G 25MM SHORT NEEDLE

    MDR report key: 2431165 · Received January 25, 2012

    Report

    Report Number
    3002987375-2012-00001
    Event Type
    Injury
    Date Received
    January 25, 2012
    Date of Event
    February 5, 2009
    Report Date
    January 12, 2012
    Manufacturer
    S.O.F.I.C. S.A.
    Product Code
    DZM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE ADVERSE REACTION WAS CONSIDERED TO BE MEDICALLY RELEVANT, THIS CASE REPORT WAS CONSIDERED SERIOUS.

    Description of Event or Problem · 1

    THE LAWYER FOR DEVICE DISTRIBUTOR (B)(6) REPORTED THAT A FEMALE PATIENT, WITH NO SPECIFIED MEDICAL HISTORY, HAS BEEN TREATED WITH A HENRY SCHEIN 27G 25MM SHORT NEEDLE FOR A ROUTINE CHECK-UP AND TOOTH FILLING ON (B)(6) 2009. WHILE UNDERGOING DENTAL WORK ON THAT DATE, THE PATIENT ALLEGED THAT THE DENTAL NEEDLE BROKE OFF IN HER JAW AND GUM, CAUSING HER PERMANENT INJURIES. THE PATIENT SUFFERED WHAT SHE SAID WAS AGONIZING, DEBILITATING AND SEVERE PAIN IN HER LEFT PTERYGOMANDIBULAR SPACE. THE NEEDLE WAS RETRIEVED BY SURGERY AND THE PATIENT SAID SHE IS EXPERIENCING LINGUAL AND INFERIOR ALVEOLAR NERVE ANESTHESIA WITHOUT IMPROVEMENT AND SPEECH DISTURBANCE. AT THE TIME OF THIS REPORT, THE PATIENT HAD FULLY RECOVERED FROM THE NEEDLE BEING BROKEN AND THE OUTCOME FOR THE TRIGEMINAL NERVE DISORDER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HENRY SCHEIN INTERN. 27G 25MM SHORT NEEDLE DENTAL NEEDLE DZM S.O.F.I.C. S.A. ME400409

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability