BEUDAMED
    FDA Adverse Event Other Summary report: N

    MOUTH PROP - BLACK, LRG SCHEIN

    MDR report key: 4541887 · Received February 20, 2015

    Report

    Report Number
    2523190-2015-00009
    Event Type
    Other
    Date Received
    February 20, 2015
    Report Date
    January 26, 2015
    Manufacturer
    INTEGRA YORK PA INC
    Product Code
    JXL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 8/28/2015 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: RETURNED TWO MOUTH PROPS IN USED CONDITION, NOT SHOWING ANY UNUSUAL MARKINGS. DEVICE HISTORY EVALUATION: NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: THERE IS NO APPLICABLE NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: THERE IS NO APPLICABLE CORRECTIVE ACTION PREVENTIVE ACTION HISTORY HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THE LAB ANALYSIS DETERMINED THE COMPOSITION MATERIAL IS NOT A SENSITIZER. THE COMPLAINT REPORT CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    DEALER REPORTS SEVERAL PATIENTS EXPERIENCED AN ALLERGIC REACTION DURING OR AFTER CONTACT WITH THE MOUTHPROP AND ONE PT EVEN DEVELOPED A MORE SEVERE ECZEMA AFTER LEAVING THE PRACTICE, WHICH WAS REPORTED BY THE DENTIST TO (B)(6). NO FURTHER INFO AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124368 MOUTH PROP - BLACK, LRG SCHEIN M54 - ORAL SURGERY JXL INTEGRA YORK PA INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1