BEUDAMED
    FDA Adverse Event Summary report: N

    ZOOM AP LAMP

    MDR report key: 3927393 · Received July 9, 2014

    Report

    Report Number
    1000582314-2014-00012
    Date Received
    July 9, 2014
    Date of Event
    May 7, 2014
    Report Date
    June 11, 2014
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INCLUDED REVIEW OF THE BATCH HISTORY RECORDS FOR THE SKU # 22-3764, LOT # 13245045. THE REVIEW OF THE BATCH HISTORY RECORDS DID NOT UNCOVER ANY ADVERSE FINDING. IN ADDITION, THE RETAIN SAMPLE FOR SKU # 22-3764, LOT # 13245045 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 DEVICE HISTORY RECORD FOR THE ZOOM AP LAMP, ZM2550, SERIAL # (B)(4) IS NOT AVAILABLE FOR REVIEW SINCE THE LAMP WAS MANUFACTURED IN 2006 AND THE RECORD RETENTION FOR THE DHR IS FIVE YEARS. BASED ON THE RESULTS OF THE INVESTIGATION AND THE INFO PROVIDED, IT APPEARS THAT THE INCIDENT HAPPENED DUE TO THE PT'S MOVEMENT DURING THE PROCEDURE POTENTIALLY EXPOSING THE PT'S INSIDE OF THE MOUTH AND LIPS TO THE WHITENING GEL.

    Description of Event or Problem · 1

    AN EXTENSIVE INVESTIGATION WAS CONDUCTED FOR COMPLAINT # (B)(4). ON (B)(6) 2014, (B)(6) CALLED TO REPORT THAT THEY HAD AN INJURY DURING A ZOOM WHITENING PROCEDURE. THEY STATED THAT PT KEPT MOVING CAUSING THE GEL TO BURN LIP. AFTER COMPLETING THE ZOOM TEETH WHITENING PROCEDURE, THE PT COMPLAINED OF VERY SENSITIVE TEETH AND SWOLLEN LIP. THE PT ENDED UP GETTING A 3RD DEGREE BURN INSIDE THE MOUTH ON THE RIGHT SIDE. THE PT'S RIGHT SIDE OF THE NECK INCLUDING THE GLANDS WAS SWOLLEN FOR A DAY. THE PT WENT TO THE EMERGENCY ROOM AND WAS GIVEN ANTIBIOTIC AND PAIN PILLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399546 ZOOM AP LAMP ZOOM AP LAMP EEG DISCUS DENTAL, LLC ZOOM AP 2.5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other