BEUDAMED
    FDA Adverse Event Summary report: N

    ZOOM CHAIRSIDE WHITENING

    MDR report key: 3830473 · Received May 23, 2014

    Report

    Report Number
    1000582314-2014-00005
    Date Received
    May 23, 2014
    Date of Event
    February 17, 2014
    Report Date
    March 11, 2014
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INCLUDED REVIEW OF THE BATCH HISTORY RECORD FOR THE SKU #(B)(4) (ZOOM WHITENING GEL), LOT# 12195001. THE REVIEW OF THE BATCH HISTORY RECORDS DID NOT UNCOVER ANY ADVERSE FINDING. IN ADDITION, THE RETAIN SAMPLE FOR SKU# (B)(4) (ZOOM WHITENING GEL), LOT# 12195001 WAS TESTED AND WAS FOUND TO BE WITHIN SPECS. NO OTHER QUALITY ISSUES WERE REVEALED DURING THE REVIEW OF THE SAID RECORDS. DURING THE INVESTIGATION, IT WAS ALSO NOTED THAT THE DENTIST APPEARED TO HAVE USED A WHITENING GEL BEYOND ITS EXPIRATION DATE. AS OF (B)(6) 2014, CUSTOMER HAS NOT PROVIDED A RETURN SAMPLE OF THE ZOOM WHITENING GEL. WE WILL CONDUCT TESTING ON THE RETURN SAMPLE (IF IT BECOMES AVAILABLE) AND DETERMINE IF SAMPLE IS WITHIN PRODUCT SPECS. THE ZOOM LAMP USED WITH THE ZOOM CHAIRSIDE WHITENING KIT WAS NOT RETURNED FOR EVAL. THERE IS NO RECORD THAT THE DENTIST HAS PURCHASED A ZOOM LAMP FROM DISCUS DENTAL, HENCE NO MFR DATE WAS PROVIDED IN THE FORM FDA 3500A. 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 DOCTOR PERFORMED A ROOT CANAL ON THE TWO TEETH MENTIONED ABOVE AFTER THE ZOOM WHITENING PROCEDURE, 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 STATING A PT EXPERIENCED PAIN AND SENSITIVITY ON TOOTH #25 AND #26 WHILE PERFORMING WHITENING PROCEDURE ON (B)(6) 2014. ROOT CANAL WAS PERFORMED ON THE TWO TEETH MENTIONED ABOVE DUE TO THE PAIN AND SENSITIVITY EXPERIENCED BY THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308042 ZOOM CHAIRSIDE WHITENING ZOOM CHAIRSIDE KIT EEG DISCUS DENTAL, LLC ZOOM AP 12195001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other