BEUDAMED
    FDA Adverse Event Summary report: N

    ZOOM CHAIRSIDE WHITENING

    MDR report key: 3830509 · Received May 23, 2014

    Report

    Report Number
    1000582314-2014-00004
    Date Received
    May 23, 2014
    Date of Event
    February 19, 2014
    Report Date
    March 11, 2014
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INCLUDED REVIEW OF THE BATCH HISTORY RECORD FOR THE SKU (B)(4), LOT# 13315047. THE REVIEW OF THE BATCH HISTORY RECORDS DID NOT UNCOVER ANY ADVERSE FINDING. IN ADDITION, THE RETAIN SAMPLE FOR SKU# (B)(4), LOT# 13315047 WAS TESTED AND WAS FOUND TO BE WITHIN SPECS. NO OTHER QUALITY ISSUES WERE REVEALED DURING THE REVIEW OF THE SAID RECORDS. THE ZOOM LAMP USED WITH THE ZOOM CHAIRSIDE WHITENING KIT WAS NOT RETURNED FOR EVAL. THE ZOOM LAMP WAS MFG IN 12/2007. THE RETENTION TIME FOR THE DEVICE HISTORY RECORD FOR THE ZOOM LAMP IS 5 YEARS. THEREFORE, THE DEVICE HISTORY RECORD IS NO LONGER AVAILABLE FOR REVIEW. BASED ON THE INVESTIGATION AND INFO PROVIDED, IT APPEARS THAT THE INCIDENT DESCRIBED IN THE COMPLAINT MIGHT BE DUE TO TOO THIN LIQUIDAM APPLIED TO THE GUMS OR IMPROPER ISOLATION OF THE GINGIVA. SINCE THE PT SOUGHT MEDICAL ATTENTION, THIS EVENT WILL BE REPORTED TO THE FDA. DISCUS WILL CONTINUE TO MONITOR THE CUSTOMER COMPLAINTS FOR SIMILAR ISSUE.

    Description of Event or Problem · 1

    DR (B)(6) CALLED ON (B)(6) 2014 AND SAID THAT A PT HAD A WHITENING PROCEDURE DONE AND ABOUT THREE HOURS LATER, THE LIPS BECAME SWOLLEN. SHE WENT TO THE EMERGENCY ROOM AND RECEIVED PAIN MEDICATION AND BENADRYL. DR (B)(6) THINKS IT WAS AN ALLERGIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308583 ZOOM CHAIRSIDE WHITENING ZOOM CHAIRSIDE KIT EEG DISCUS DENTAL, LLC ZOOM 2.6 13315047

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other