BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT RINN A DIVISION OF DENTSPLY

    MDR report key: 514804 · Received February 25, 2004

    Report

    Report Number
    MW1031339
    Event Type
    Injury
    Date Received
    February 25, 2004
    Manufacturer
    CRESCENT RINN A DIV OF DENTSPLY INTERNATIONAL, INC.
    Product Code
    EHK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RUBBER CUP POPS OFF FROM THE PLASTIC SHAFT IF THE PT EVEN BITES LIGHTLY ON THIS ATTACHMENT CAUSING EITHER A CHOKING OR ASPIRATION RISK. THERE WAS NO INJURY TO PT, BUT REPORTER IS CONCERNED THAT A HIGH RISK IS POSSIBLE IF THE CAP COMES OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRESCENT RINN A DIVISION OF DENTSPLY R.A. WEBBED CUPS EHK CRESCENT RINN A DIV OF DENTSPLY INTERNATIONAL, INC. PRODUCT #C200030 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *