BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON RCI BITE GUARD MOLAR BITE BLOCK

    MDR report key: 2102864 · Received May 3, 2011

    Report

    Report Number
    3004365956-2011-00193
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Report Date
    April 8, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BRW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE OR LOT NUMBER IS AVAILABLE FOR THE MANUFACTURER TO INVESTIGATE. CONCLUSIONS: NO CONCLUSION CAN BE ESTABLISHED BASED ON LACK OF SAMPLE. NO CORRECTIVE ACTION WAS TAKEN.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT EXTERNAL PORTION OF THE BITE GUARD SEPARATED FROM THE PIECE THAT SITS INTERNALLY BETWEEN THE PATIENT'S MOLARS WHICH WAS CAUSING DIFFICULTY TO REMOVE THE BITE GUARD FROM THE PATIENT'S MOUTH. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON RCI BITE GUARD MOLAR BITE BLOCK BITE GUARD MOLAR BRW TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1