BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 10281374 · Received July 16, 2020

    Report

    Report Number
    1000582314-2020-00003
    Event Type
    Injury
    Date Received
    July 16, 2020
    Date of Event
    June 17, 2020
    Report Date
    July 15, 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 (B)(6) 2020 IN WHICH A PATIENT HAD AN ADVERSE EFFECT IN THE FORM OF THROAT PAIN DURING AND AFTER THE LED LAMP IN-OFFICE ZOOM WHITENING PROCEDURE. 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, AND NO NON-COMPLIANCE. 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. NON-ADDITIONAL INFORMATION WAS PROVIDED. PATIENT SOUGHT MEDICAL ATTENTION; TREATMENT IS UNKNOWN. THE GEL AND KIT WERE USED UP DURING PROCEDURE AND WERE NOT RETURNED. REVIEW OF COMPLAINT HISTORY FROM JANUARY 2018 TO JULY 2020, NO THROAT PAIN WAS REPORTED IN THE USA. HOWEVER, ONE SIMILAR COMPLAINT WAS REPORTED IN (B)(6). RETAIN SAMPLE OF 25% GEL SKU: 22-3464 LOT: 20122007 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, INGESTION OF GEL THAT LEADS TO BURNING OF INTERNAL ORGANS IS COVERED IN THE RISK REPORT (B)(4), HBSRA, ZOOM WS LIGHT ACC TOOTH WHITENING SYSTEM. NOTIFIED POHC/DESIGN SITE TO REVIEW RISK MANAGEMENT FILE AND UPDATE AS NEEDED. DENTAL OFFICE REPORTED THAT THE PATIENT IS HEALING. NO FURTHER INFORMATION WAS PROVIDED. 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: 20122007, CHAIRSIDE KIT SKU: 881055701540 LOT: 20071020 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: 20122007. NO CORRECTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2020 IN WHICH A PATIENT HAD AN ADVERSE EFFECT IN THE FORM OF THROAT PAIN DURING AND AFTER THE LED LAMP IN-OFFICE ZOOM WHITENING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749286 PHILIPS ZOOM ZOOM CHAIRSIDE LAMP EEG DISCUS DENTAL, LLC 22-3764, ZM3000 AND 881055701540 20122007 & 20071020 00075020035004

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization