BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 7980402 · Received October 18, 2018

    Report

    Report Number
    1000582314-2018-00006
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    September 26, 2018
    Report Date
    October 18, 2018
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    UDI-DI
    00075020035004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(4) 2018, IN WHICH THE DENTAL OFFICE CLAIMED PATIENT WAS HAVING SENSITIVITY ISSUES AFTER THE IN-OFFICE WHITENING PROCEDURE AND PATIENT WENT TO THE EMERGENCY ROOM. THE KIT AND GEL WERE USED UP DURING THE PROCEDURE AND WERE NOT RETURNED. THE RETAIN SAMPLE OF THE WHITENING GEL, SKU: 22-3764, LOT: 18194028, WAS TESTED ON (B)(4) 2018, AND RESULTS WERE WITHIN SPECIFICATIONS. ALSO REVIEWED THE DEVICE/BATCH HISTORY RECORDS OF WHITENING KIT, SKU: 881055701540, LOT: 18201006 AND GEL, SKU: 22-3764, LOT: 18194028. NO OUT OF SPECIFICATION OR DISCREPANCY WAS FOUND. REVIEWED COMPLAINTS HISTORY, NO OTHER SIMILAR INCIDENT WAS REPORTED FROM THE SAME LOT NUMBERS. REVIEWED DIRECTION FOR USE OF THE KIT. THE DFU DESCRIBES STEPS FOR CANDIDATE QUALIFICATION, WARNINGS, INGREDIENTS, TREATMENT FOR SENSITIVITY AND OTHER PRECAUTIONS. NO PRODUCT FAILURE OR OUT OF SPECIFICATIONS WAS FOUND IN THE PRODUCT. POTENTIAL OF SENSITIVITY MAY BE DUE TO A PREEXISTING SENSITIVITY. BASED ON THE INVESTIGATION RESULTS AND AVAILABLE INFORMATION, DISCUS DENTAL CONCLUDES THERE WAS NO MALFUNCTION OR FAILURE IN THE PRODUCT. NO CORRECTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(4) 2018, IN WHICH THE DENTAL OFFICE CLAIMED PATIENT WAS HAVING SENSITIVITY ISSUES AFTER THE IN-OFFICE WHITENING PROCEDURE AND PATIENT WENT TO THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817950 PHILIPS ZOOM ZOOM CHAIRSIDE KIT EEG DISCUS DENTAL, LLC 881055701540 18201006 00075020035004

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization