BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 10980023 · Received December 9, 2020

    Report

    Report Number
    1000582314-2020-00005
    Event Type
    Injury
    Date Received
    December 9, 2020
    Date of Event
    November 17, 2020
    Report Date
    December 9, 2020
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    UDI-DI
    00075020035004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON 11/17/2020 IN WHICH A PATIENT HAD WHITE BLISTER ON BOTH UPPER AND LOWER LIP AFTER ZOOM TREATMENT. NOTE: PATIENT HAS ALLERGIES ON PENICILLIN AND LATEX. THIS INCIDENT DID NOT CAUSE A DEATH, OR A SERIOUS INJURY. HOWEVER, SINCE THE PATIENT SOUGHT MEDICAL ATTENTION AND WAS PRESCRIBED ANTIBIOTICS, THIS INCIDENT IS BEING REPORTED TO FDA. NO OUT OF SPECIFICATIONS WAS FOUND IN THE PRODUCT. NO IMPACT ON SHIPPED PRODUCTS FROM THE SAME LOT OR OTHER LOTS PRODUCED. NO CONTAINMENT ACTION IS REQUIRED. NO MISUSE WAS IDENTIFIED BASED ON COMPLAINT DESCRIPTION. THE 25% GEL AND THE CHAIRSIDE KIT WERE WITHIN THE EXPIRATION DATE. RELIEF ACP MEDICAL DEVICE WAS NOT USED OR INVOLVED DURING TEETH WHITENING PROCEDURE. DENTAL OFFICE REPORTED THAT THE PATIENT IS HEALING SLOWLY. PATIENT IS DIABETIC AND WAS SUPPOSED TO EAT TO AT 1PM AND PROCEDURE FINISHED AT 3PM. THEREFORE, SHE WAS LIGHTHEADED AND SWEATING FROM LOW BLOOD SUGAR. PATIENT HAD A GRANOLA BAR AT THE OFFICE AND FELT BETTER AFTER THE FACT. HOWEVER, THE BURN DIDN'T HEAL AS FAST AND PATIENT WAS STILL IN PAIN DAYS AFTER. PATIENT SOUGHT MEDICAL ATTENTION AND WAS PRESCRIBED PAIN RELIEVER AND ANTIBIOTIC. THE GEL AND KIT WERE USED UP DURING PROCEDURE AND WERE NOT RETURNED. RETAIN SAMPLE OF 25% GEL SKU: 22-3764 LOT: 20006011 WAS SUBMITTED TO THE LAB FOR TESTING AND THE RESULTS WERE WITHIN SPECIFICATIONS. REVIEWED DIRECTION FOR USE OF THE KIT. THE DFU DESCRIBES STEPS FOR CANDIDATE QUALIFICATION, WARNINGS, INGREDIENTS, SAFETY DIRECTIONS INCLUDING AVOID CONTACT WITH SOFT TISSUE AND SALIVARY FLOW AND OTHER PRECAUTIONS. REVIEWED RISK MANAGEMENT REPORT FOR ZOOM WS LIGHT ACC TOOTH WHITENING SYSTEM. THERMAL BURNS TO TO LIPS/GUMS REMAINS WITHIN ACCEPTABLE LEVEL. DENTAL OFFICE REPORTED THAT THE PATIENT IS HEALING SLOWLY. BASED ON THE INVESTIGATION, THERE WAS NO PRODUCT FAILURE AND WE ARE UNABLE TO CONCLUDE ACTUAL CAUSE. REVIEWED DEVICE HISTORY RECORD FOR 25% GEL SKU: 22-3764 LOT: 20006011 EXPIRATION DATE: 05/24/2021, CHAIRSIDE KIT SKU: 881055701540 LOT: 19361006 EXPIRATION DATE: 02/15/2021 WITH UDI NUMBER (B)(4) AND WHITESPEED LAMP SKU: ZM3000 SERIAL # (B)(4). NO OUT OF SPECIFICATION OR DISCREPANCY WAS FOUND IN THE RECORDS. BASED ON THE INVESTIGATION RESULTS AND AVAILABLE INFORMATION, DISCUS DENTAL CONCLUDES THERE WAS NO FAILURE IN RETAIN SAMPLE OF 25% GEL SKU: 22-3764 LOT: 20006011. NO CORRECTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2020 IN WHICH PATIENT HAD A WHITE BLISTER ON BOTH UPPER AND LOWER LIP AFTER ZOOM TREATMENT. NOTE: PATIENT HAS ALLERGIES ON PENICILLIN AND LATEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1443325 PHILIPS ZOOM ZOOM CHAIRSIDE LAMP AND CHAIRSIDE KIT EEG DISCUS DENTAL, LLC 22-3764, ZM3000 AND 881055701540 20006011 & 19361006 00075020035004

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization