BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 9766220 · Received February 27, 2020

    Report

    Report Number
    1000582314-2020-00001
    Event Type
    Injury
    Date Received
    February 27, 2020
    Date of Event
    January 29, 2020
    Report Date
    February 21, 2020
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    UDI-DI
    00075020035004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2020 IN WHICH A PATIENT EXPERIENCED ALLERGY "BREATHING DIFFICULTIES", "RED BLUSHES/BIG HIVES ON NECK AND THROAT" WITH THE 25 %HP GEL 1ST & 2ND IN OFFICE ZOOM. THE DENTIST ATTEMPTED TO UNDERGO ZOOM WHITENING TREATMENT, THE FIRST ATTEMPT WAS STOPPED WHEN SEEING THE ALLERGIC REACTION IN THE FORM OF BREATHING DIFFICULTIES OF THE PATIENT. A SECOND ATTEMPT OF ZOOM TREATMENT WAS STOPPED AGAIN AS THE ALLERGIC REACTION OF "RED BLUSHES AND BIG HIVES ON THE NECK AND THROAT". THE KIT AND GEL WERE USED UP DURING PROCEDURE AND WERE NOT RETURNED. REVIEWED THE DEVICE/BATCH HISTORY RECORDS OF CHAIRSIDE KIT SKU: 881055701540, 25% GEL LOT: 19063027 SKU: 22-3764 LOT: 19059023 AND ZOOM WHITESPEED LAMP SKU: ZM3000 SERIAL NUMBER: (B)(4). NO OUT OF SPECIFICATION OR DISCREPANCY WAS FOUND. RETAIN SAMPLE OF ZOOM 25% GEL SKU: 22-3764 LOT: 19059023, WAS TESTED AND RESULTS WERE WITHIN SPECIFICATIONS. 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, AND OTHER PRECAUTIONS. POTENTIAL CAUSE MAY BE AN ALLERGIC REACTION TO ONE OF THE PRODUCT INGREDIENTS. NO HOSPITALIZATION OR PRESCRIPTION DRUG REQUIRED TO TREAT ALLERGY. 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. WE WILL CONTINUE TO MONITOR THE TREND.

    Description of Event or Problem · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2020 IN WHICH A PATIENT EXPERIENCED ALLERGY "BREATHING DIFFICULTIES", "RED BLUSHES/BIG HIVES ON NECK AND THROAT" WITH THE 25 %HP GEL 1ST & 2ND IN OFFICE ZOOM. THE DENTIST ATTEMPTED TO UNDERGO ZOOM WHITENING TREATMENT, THE FIRST ATTEMPT WAS STOPPED WHEN SEEING THE ALLERGIC REACTION IN THE FORM OF BREATHING DIFFICULTIES OF THE PATIENT. A SECOND ATTEMPT OF ZOOM TREATMENT WAS STOPPED AGAIN AS THE ALLERGIC REACTION OF "RED BLUSHES AND BIG HIVES ON THE NECK AND THROAT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228858 PHILIPS ZOOM ZOOM CHAIRSIDE KIT EEG DISCUS DENTAL, LLC 881055701540 19063027 00075020035004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other