BEUDAMED
    FDA Adverse Event Summary report: N

    ZOOM AP LAMP

    MDR report key: 3927368 · Received July 9, 2014

    Report

    Report Number
    1000582314-2014-00011
    Date Received
    July 9, 2014
    Report Date
    June 12, 2014
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INCLUDED REVIEW OF BATCH HISTORY RECORD FOR ZM2666 ZOOM CH KIT LOT # 13336048 (CHAIRSIDE GEL 22-3764 LOT # 13350030). THE REVIEW OF THE BATCH HISTORY RECORD DID NOT UNCOVER ANY ADVERSE FINDING. IN ADDITIONAL, THE RETAIN SAMPLE FOR SKU # 22-3764 LOT #13350030 WAS TESTED AND IT WAS FOUND TO BE WITHIN SPECIFICATIONS. NO OTHER QUALITY ISSUE WAS REVEALED DURING THE REVIEW OF SAID RECORDS. THE DEVICE HISTORY RECORD FOR THE ZOOM AP LAMP, ZM2500 SERIAL # 02376 IS NOT AVAILABLE FOR REVIEW SINCE THE LAMP WAS MANUFACTURED IN 2005 AND THE RECORD RETENTION FOR THE DHR IS FIVE YEARS. DISCUS DENTAL WILL CONTINUE TO MONITOR SIMILAR ISSUES. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    HOLD -SDAON 05/20/2014, CHRIS FROM THE DENTAL CLINIC CALLED ABOUT A PATIENT THAT HAD AN ULCER ON THE GINGIVA OF THE BOTTOM JAW FROM USING THE SMALL GREY COLOR RETRACTOR. THEY STATED THAT THE PATIENT HAD A HARD TIME GETTING THE SMALL RETRACTOR IN AS IT WAS STILL TOO BIG FOR THIS PATIENT. THEY ALSO STATED THAT THE PATIENT IS IN PAIN AND HAS BEEN RINSING WITH WARM WATER AND SALT. PATIENT ALSO COMPLAINED OF SENSITIVELY, THE DENTAL OFFICE GAVE THE PATIENT A CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400148 ZOOM AP LAMP WHITENING LAMP EEG DISCUS DENTAL, LLC ZM2500

    Patients

    Seq Age Sex Outcome Treatment
    1 Other