BEUDAMED
    FDA Adverse Event Summary report: N

    ZOOM AP CHAIRSIDE WHITENING

    MDR report key: 3862791 · Received June 10, 2014

    Report

    Report Number
    1000582314-2014-00007
    Date Received
    June 10, 2014
    Date of Event
    March 26, 2014
    Report Date
    May 19, 2014
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXTENSIVE INVESTIGATION WAS CONDUCTED FOR COMPLAINT # (B)(4). ON (B)(6) 2014, THE OFFICE REPORTED THAT THEY DID A ZOOM PROCEDURE ON A PATIENT AND THE PATIENT'S GUM AREA BETWEEN 8 & 9 TURNED BLACK AND PUFFY. DENTIST HAD THE PATIENT USE ANTISEPTIC RINSE. PATIENT IS NOW FINE. THE INVESTIGATION INCLUDED REVIEW OF BATH HISTORY RECORD FOR ZM2665 ZOOM CH KIT LOT #14052001 (CHAIRSIDE GEL 22-3764 LOT #14048021). IN ADDITION, THE RETAIN SAMPLE FOR SKU (B)(4), LOT #14048021 WAS TESTED AND IT WAS FOUND TO BE WITHIN SPECIFICATIONS. NO OTHER QUALITY ISSUE WAS REVEALED DURING THE REVIEWED OF SAID RECORDS. THE DEVICE HISTORY RECORD FOR THE ZOOM AP LAM, ZM2501 SERIAL # (B)(4) IS NOT AVAILABLE FOR REVIEW SINCE THE LAMP WAS MANUFACTURED IN 2005 AND THE RECORD RETENTION FOR THE DHR IS FIVE YEARS. BASED ON THE INVESTIGATION, IT APPEARS THAT THIS IS AN ISOLATED INCIDENT. DISCUS DENTAL WILL CONTINUE TO MONITOR FOR SIMILAR INCIDENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE OFFICE REPORTED THAT THEY DID A ZOOM PROCEDURE ON A PATIENT AND THE PATIENT'S GUM AREA BETWEEN 8 & 9 TURNED BLACK AND PUFFY. DENTIST HAD THE PATIENT USE ANTISEPTIC RINSE. PATIENT IS NOW FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341240 ZOOM AP CHAIRSIDE WHITENING ZOOM AP CHAIRSIDE WHITENING EEG DISCUS DENTAL, LLC ZOOM AP 14048021

    Patients

    Seq Age Sex Outcome Treatment
    1 Other