BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDWEST E PLUS 1:5 HIGHSPEED ATTACHMENT

    MDR report key: 6983428 · Received October 27, 2017

    Report

    Report Number
    1419322-2017-00265
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Report Date
    October 27, 2017
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EFB
    PMA / PMN Number
    K131319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED TO PRECLUDE A SERIOUS INJURY IN THIS EVENT, THERE HAVE BEEN PREVIOUSLY REPORTED EVENTS INVOLVING A SIMILAR DEVICE THAT RESULTED IN THE NEED FOR MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT THE CAP UNSCREWED FROM A MIDWEST E PLUS 1:5 ATTACHMENT WHILE IN USE. THE REPORTED COMPLAINT DID NOT RESULT IN AN INJURY OR NEED FOR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763433 MIDWEST E PLUS 1:5 HIGHSPEED ATTACHMENT HANDPIECE, AIR-POWERED, DENTAL EFB DENTSPLY PROFESSIONAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1