BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCP BITE-BLOCK

    MDR report key: 757140 · Received September 1, 2006

    Report

    Report Number
    1418963-2006-00401
    Event Type
    Injury
    Date Received
    September 1, 2006
    Report Date
    August 3, 2006
    Manufacturer
    DENTSPLY RINN
    Product Code
    EGZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE BITE-BLOCK USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'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. THE DEVICE WAS RETURNED, EVALUATED FOR ENDOTOXIN LEVELS, AND FOUND TO CONTAIN >=4.8 AND >9.6 EU/DEVICE, UNDER THE PHARMACOPEIA LIMIT OF 20 EU/DEVICE FOR PYROGEN FREE DEVICES. ALSO, THE PRODUCT FAMILY HAS BEEN TESTED FOR IRRITATION, SENSITIZATION, AND CYTOTOXICITY PROPERTIES, WITH ALL TESTS PASSING THE ACCEPTANCE CRITERIA. ADDITIONALLY, THE DOCTOR STATED THAT STEAM AUTOCLAVING IS USED FOR STERILIZATION. THE NUMBER OF USES/STERILIZATIONS OF THE DEVICE IS UNKNOWN. PLEASE NOTE THAT WHILE THE EXACT MANUFACTURE DATE IS UNKNOWN, THE DEVICE'S WHITE COLOR INDICATES IT WAS MANUFACTURED IN OR PRIOR TO 1998.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S TONGUE BEGAN TO SWELL AFTER A XCP BITE-BLOCK WAS PLACED INTO THE MOUTH. THE PATIENT WAS ADMINISTERED BENADRYL AND THE SWELLING SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCP BITE-BLOCK EGZ EGZ DENTSPLY RINN NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention