BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 7900055 · Received September 21, 2018

    Report

    Report Number
    1000582314-2018-00005
    Event Type
    Injury
    Date Received
    September 21, 2018
    Date of Event
    August 29, 2018
    Report Date
    September 21, 2018
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    UDI-DI
    00075020034991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(4) 2018, IN WHICH THE PATIENTS FACE BEGAN TO SWELL AFTER A ZOOM CHAIRSIDE WHITENING PROCEDURE. THE PATIENT ALSO DEVELOPED NUMBNESS AND SWELLING OF HER LOWER LIP. THE PATIENT WENT TO URGENT CARE AND WAS GIVEN DEXAMETHASONE INJECTION, 3 DOSES OF BENADRYL AND WAS PRESCRIBED 20MLG PREDNISONE. 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: 18165002, WAS TESTED ON 08/31/2018, AND RESULTS WERE WITHIN SPECIFICATIONS. REVIEWED THE DEVICE/BATCH HISTORY RECORDS OF WHITENING KIT, SKU: 881055601540, LOT: 18165003 AND GEL, SKU: 22-3764, LOT: 18165002. NO OUT OF SPECIFICATION OR DISCREPANCY WAS FOUND. REVIEWED COMPLAINTS HISTORY, NO OTHER SIMILAR INCIDENT WAS REPORTED FROM THE SAME LOT NUMBERS. REVIEWED COMPLAINTS HISTORY OF THE PAST 3 YEARS. THE RATE FOR SIMILAR INCIDENTS IS LOW. REVIEWED DIRECTION FOR USE OF THE KIT. THE DFU DESCRIBES STEPS FOR CANDIDATE QUALIFICATION, WARNINGS, INGREDIENTS, AND OTHER PRECAUTIONS. ALL INGREDIENTS ARE LISTED ON LABELING. NO PRODUCT FAILURE OR OUT OF SPECIFICATIONS WAS FOUND IN THE PRODUCT. POTENTIAL CAUSE MAY BE AN ALLERGIC REACTION TO PRODUCT INGREDIENTS. 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. PATIENT IS DOING MUCH BETTER, THE SWELLING IS GONE AND SHE IS FINE.

    Description of Event or Problem · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(4) 2018, IN WHICH THE PATIENTS FACE BEGAN TO SWELL AFTER A ZOOM CHAIRSIDE WHITENING PROCEDURE. THE PATIENT ALSO DEVELOPED NUMBNESS AND SWELLING OF HER LOWER LIP. THE PATIENT WENT TO URGENT CARE AND WAS GIVEN DEXAMETHASONE INJECTION, 3 DOSES OF BENADRYL AND WAS PRESCRIBED 20MLG PREDNISONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738559 PHILIPS ZOOM ZOOM CHAIRSIDE KIT EEG DISCUS DENTAL, LLC 881055601540 18165003 00075020034991

    Patients

    Seq Age Sex Outcome Treatment
    1 Other