BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZOOM CHAIRSIDE WHITENING KIT

    MDR report key: 3576811 · Received December 30, 2013

    Report

    Report Number
    1000582314-2013-00007
    Event Type
    Other
    Date Received
    December 30, 2013
    Date of Event
    October 31, 2013
    Report Date
    November 12, 2013
    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

    THE INVESTIGATION INCLUDED REVIEW OF THE BATCH HISTORY RECORDS FOR THE SKY # 22-3764 LOT # 13140026. THE REVIEW OF THE BATCH HISTORY RECORDS DID NOT UNCOVER ANY ADVERSE FINDING. IN ADDITION, THE RETAIN SAMPLE FOR SKU # 22-3764 LOT # 13140026 WAS TESTED AND WAS FOUND TO BE WITHIN SPECIFICATIONS. RETURNED SAMPLE WAS REC'D FROM THE CUSTOMER AND WAS SENT TO THE QC LAB FOR TESTING BUT THERE WAS NOT ENOUGH SAMPLE TO PERFORM THE REQUIRED TESTING. 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 AP LAMP, 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT DEVELOPED SWOLLEN RED LIPS AFTER A WHITENING PROCEDURE. LOOKED LIKE BURNS. PATIENT SOUGHT MEDICAL HELP. THE DOCTOR SAID PATIENT HAD SECOND DEGREE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680725 ZOOM CHAIRSIDE WHITENING KIT NA EEG DISCUS DENTAL LLC ZOOM AP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other