BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 9795841 · Received March 5, 2020

    Report

    Report Number
    1000582314-2020-00002
    Event Type
    Injury
    Date Received
    March 5, 2020
    Date of Event
    February 6, 2020
    Report Date
    March 5, 2020
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    UDI-DI
    00075020034991
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2020 IN WHICH A PATIENT WHO DID THE WHITENING ON FRIDAY (B)(6) 2020 AND AFTER THE WHITENING, HE EXPERIENCED CERTAIN EFFECTS LIKE CHILL, SHAKING AND FATIGUE. THE FOLLOWING DAY, THESE SYMPTOMS WERE GONE. HOWEVER, STARTED TO HAVE HERPES ALL OVER HIS LIP. COLD SORE BEGAN TO APPEAR. MORE APPEARED ON SUNDAY AND GREW IN SIZE. THE KIT AND GEL WERE USED UP DURING PROCEDURE AND WERE NOT RETURNED. REVIEWED THE DEVICE/BATCH HISTORY RECORDS OF CHAIRSIDE KIT SKU: 881055601540 LOT: 19308006 AND SKU: 22-3764 LOT: 19310003. NO OUT OF SPECIFICATION OR DISCREPANCY WAS FOUND. RETAIN SAMPLE OF ZOOM 25% GEL SKU: 22-3764 LOT: 19310003, WAS TESTED AND RESULTS WERE WITHIN SPECIFICATIONS. REVIEWED COMPLAINTS HISTORY, NO OTHER SIMILAR INCIDENT WAS REPORTED FROM THE SAME LOT NUMBERS. REVIEWED DIRECTION FOR USE OF THE KIT. THE DFU DESCRIBES STEPS FOR CANDIDATE QUALIFICATION, WARNINGS, INGREDIENTS, AND OTHER PRECAUTIONS. PER COMPLAINT INFORMATION, PATIENT HAS CARRIED THE HERPES SIMPLEX VIRUS ALL HIS LIFE. NO ADDITIONAL INFORMATION REGARDING THE PATIENT CONDITION WAS AVAILABLE AFTER 3 ATTEMPTS WERE MADE TO RETRIEVE INFORMATION. BASED ON THE INVESTIGATION RESULTS AND AVAILABLE INFORMATION, DISCUS DENTAL CONCLUDES THERE WAS NO MALFUNCTION OR FAILURE IN THE PRODUCT. NO CORRECTIVE ACTIONS ARE REQUIRED. WE WILL CONTINUE TO MONITOR THE TREND.

    Description of Event or Problem · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2020 IN WHICH A PATIENT WHO DID THE WHITENING ON FRIDAY (B)(6) 2020 AND AFTER THE WHITENING, HE EXPERIENCED CERTAIN EFFECTS LIKE CHILL, SHAKING AND FATIGUE. THE FOLLOWING DAY, THESE SYMPTOMS WERE GONE. HOWEVER, STARTED TO HAVE HERPES ALL OVER HIS LIP. THE PATIENT SOUGHT MEDICAL ATTENTION AND WAS PRESCRIBED MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258596 PHILIPS ZOOM ZOOM CHAIRSIDE KIT EEG DISCUS DENTAL, LLC 881055601540 19308006 00075020034991

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization