BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDWEST RDH FREEDOM OUTER SHEATH

    MDR report key: 3855173 · Received May 30, 2014

    Report

    Report Number
    2424472-2014-00003
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 2, 2014
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EKX
    PMA / PMN Number
    K110753
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVAL AND THE SERIAL NUMBER WAS NOT PROVIDED FOR A DHR REVIEW.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PT EXPERIENCED AN "EXTERNAL REACTION" ON HER FACE IN THE AREA WHERE THE METAL SHEATH OF A RDH FREEDOM HANDPIECE TOUCHED. THE OUTCOME IS UNK AS OF THIS MDR EVAL. HOWEVER, THERE IS NO INDICATION THAT INTERVENTION WAS REQUIRED. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320046 MIDWEST RDH FREEDOM OUTER SHEATH DENTAL HANDPIECE AND ACCESSORIES EKX DENTSPLY PROFESSIONAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other