BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRY TIPS

    MDR report key: 5957221 · Received September 16, 2016

    Report

    Report Number
    0002134751-2016-00001
    Event Type
    Injury
    Date Received
    September 16, 2016
    Date of Event
    August 15, 2016
    Report Date
    September 15, 2016
    Manufacturer
    YOUNG MICROBRUSH LLC
    Product Code
    KHR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS CONFIRMED THAT THE PRODUCT DID NOT CONTAIN ANY OF THE ITEMS THAT THE PATIENT WAS REPORTED TO BE ALLERGIC TO. PRODUCT NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    THE DENTIST REPORTS AN ALLERGIC REACTION OF A PATIENT AFTER "DRY TIPS SMALL" HAVE BEEN PUT IN THE PATIENTS MOUTH. (REF NO.: 291543; BATCH: 275981). THE PATIENT GOT A LOCAL ANESTHESIA WITH ULTRACAIN DS FORTE. APPROXIMATELY 45MIN LATER IN THE PROCEDURE THE DRY TIP HAS BEEN PUT INTO THE PATIENTS MOUTH AND IMMEDIATELY AFTER THAT, THE LEFT HALF OF THE FACE BEGAN TO SWELL AND GOT REDDENED (ERYTHEMA). THE REACTION WAS VISIBLE ON THE LEFT SIDE OF THE FACE UP TO THE PATIENTS EYE. THE DENTIST TOOK OUT THE DRY TIP IMMEDIATELY AND COOLED THE FACE, WHICH REDUCED THE SWELLING A LITTLE. IN ADDITION AN AMBULANCE HAS BEEN CALLED. IT WAS KNOWN THAT THE PATIENT HAS A LATEX AND A WOOD RESIN ALLERGY. THEREFORE THE PATIENT WAS TREATED LATEX-FREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608346 DRY TIPS SALIVA ABSORBENT KHR YOUNG MICROBRUSH LLC 291543 27598-1

    Patients

    Seq Age Sex Outcome Treatment
    1