BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 6685182 · Received July 3, 2017

    Report

    Report Number
    1000582314-2017-00006
    Event Type
    Injury
    Date Received
    July 3, 2017
    Date of Event
    June 7, 2017
    Report Date
    July 3, 2017
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) DENTAL RECEIVED A COMPLAINT ON (B)(6) 2017, IN WHICH PATIENT EXPERIENCED A PAIN DURING ZOOM IN-OFFICE WHITENING PROCEDURE, AND A POSSIBLE ALLERGIC REACTION IN THE SAME DAY AT HOME AFTER THE PROCEDURE ON (B)(6) 2017. THE PATIENT'S THROAT CLOSED, LOST HIS VOICE AND EXPERIENCED RUNNY NOSE. THE FAMILY DOCTOR PRESCRIBED ANTIBIOTICS. INVESTIGATION: THE RETAIN SAMPLE OF THE WHITENING GEL, SKU: 22-3764, LOT: 17040004, WAS TESTED ON (B)(6) 2017, AND RESULTS WERE WITHIN SPECIFICATIONS. REVIEWED THE DEVICE/BATCH HISTORY RECORDS OF GEL, SKU: 22-3764, LOT: 17040004, ZOOM WHITENING KIT, SKU: 881055601540, LOT: 17020028, (B)(4), AND ZOOM WHITESPEED LAMP, SKU: ZM3000, SN: (B)(4). NO OUT OF SPECIFICATION OR DISCREPANCY WAS FOUND. REVIEWED COMPLAINTS HISTORY, NO OTHER SIMILAR INCIDENT WAS REPORTED FROM THE SAME LOT NUMBERS. THE KIT AND GEL WERE USED UP DURING THE PROCEDURE AND WERE NOT RETURNED. REVIEWED DIRECTION FOR USE OF THE KIT. THE DFU DESCRIBES CANDIDATE QUALIFICATION, WARNINGS, INGREDIENTS, AND OTHER PRECAUTIONS. POTENTIAL CAUSE MAY BE AN ALLERGIC REACTION TO ONE OF THE PRODUCT INGREDIENTS. BASED ON THE INVESTIGATION RESULTS AND AVAILABLE INFORMATION, DISCUS DENTAL CONCLUDES THERE WAS NO MALFUNCTION OR FAILURE IN THE PRODUCT. (B)(4). THE WHITENING KIT AND GEL WERE USED.

    Description of Event or Problem · 1

    (B)(6) DENTAL RECEIVED A COMPLAINT ON (B)(6) 2017, IN WHICH PATIENT EXPERIENCED A PAIN DURING ZOOM IN-OFFICE WHITENING PROCEDURE, AND A POSSIBLE ALLERGIC REACTION IN THE SAME DAY AT HOME AFTER THE PROCEDURE ON (B)(6) 2017. THE PATIENT'S THROAT CLOSED, LOST HIS VOICE AND EXPERIENCED RUNNY NOSE. THE FAMILY DOCTOR PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465712 PHILIPS ZOOM ZOOM CHAIRSIDE WHITENING KIT AND GEL EEG DISCUS DENTAL, LLC 22-3764 17040004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other