BEUDAMED
    FDA Adverse Event Summary report: N

    ZOOM WHITENING LAMP

    MDR report key: 3927369 · Received July 9, 2014

    Report

    Report Number
    1000582314-2014-00010
    Date Received
    July 9, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 6, 2014
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXTENSIVE INVESTIGATION WAS CONDUCTED FOR COMPLAINT # (B)(4). THE INVESTIGATION INCLUDED REVIEW OF THE BATCH HISTORY RECORDS FOR THE SKU # 22-3764 LOT # 14083035. THE REVIEW OF THE BATCH HISTORY RECORDS DID NOT UNCOVER ANY ADVERSE FINDING. IN ADDITION, THE RETAIN SAMPLE FOR SKU # 22-3764 LOT # 14083035 WAS TESTED AND WAS FOUND TO BE WITHIN SPECIFICATIONS. NO RETURNED SAMPLE WAS RECEIVED FROM THE CUSTOMER. NO OTHER QUALITY ISSUES WERE REVEALED DURING THE REVIEW OF THE SAID RECORDS. THE INVESTIGATION ALSO INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD FOR THE ZOOM WHITESPEED LAMP, ZM3000 SERIAL # (B)(4) AND WAS FOUND TO BE WITHIN MANUFACTURING SPECIFICATIONS AT THE TIME OF SHIPMENT. THE REVIEW OF THE DEVICE HISTORY RECORD DID NOT UNCOVER ANY ADVERSE FINDING. DISCUS DENTAL WILL CONTINUE TO MONITOR SIMILAR ISSUES.

    Description of Event or Problem · 1

    THE DENTAL CLINIC CALLED AND STATED THAT THE PATIENT EXPERIENCED BURNING SENSATION ON TONGUE AFTER ZOOM WHITENING PROCEDURE. THE CALLER INDICATED THAT THE PATIENT DID NOT WANT THE DENTAL CHAIR TO BE RECLINED EVEN AFTER IT WAS EXPLAINED THAT THERE IS A POSSIBILITY THAT THE SALIVA WILL BUILD UP. DURING THE WHITENING PROCEDURE, THE PATIENT KEPT PUSHING THE TONGUE OUT CAUSING MOVEMENT OF THE MATERIALS IN THE MOUTH. TOWARDS THE LAST 15 MINUTES, THE PATIENT PUSHED THE TONGUE OUT AND HAD A BURNING SENSATION. PATIENT LEFT WITHOUT COMPLAINING BUT CALLED THE NEXT DAY WITH A BLISTER ON THE TONGUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400287 ZOOM WHITENING LAMP ZOOM LAMP EEG DISCUS DENTAL, LLC ZM3000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other