BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 8679709 · Received June 7, 2019

    Report

    Report Number
    1000582314-2019-00002
    Event Type
    Injury
    Date Received
    June 7, 2019
    Date of Event
    May 11, 2019
    Report Date
    June 6, 2019
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2019, IN WHICH THE DENTAL HYGIENIST CALLED IN AND SAID THEY HAD ZOOM WHITENING PROCEDURE IN OFFICE ON SATURDAY(B)(6) 2019 AND (B)(6) 2019 THE PATIENT HAD GINGIVAL BLEEDING. THE PATIENT WAS REFERRED TO EMERGENCY ROOM. BASED ON THE INVESTIGATION, THIS OFFICE HAS NOT ORDERED PRODUCT FROM US SINCE 2015. LAST ORDER WAS ZOOM KITS WITH SKU: ZM2665, LOT: 15225011, EXPIRATION DATE: 9/25/2016 AND WHITENING GEL, SKU: 22-3764, LOT: 15232004 WITH EXPIRATION DATE: 1/7/2017. THIS OFFICE HAS A PARENT COMPANY THAT ORDERS PRODUCT REGULARLY. BASED ON THE TEST RESULT FROM PREVIOUS LOTS SHIPPED TO PARENT COMPANY, NO PRODUCT FAILURE OR 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. THE KIT AND GEL WERE USED UP DURING THE PROCEDURE AND WERE NOT RETURNED. THE RETAIN SAMPLE OF THE WHITENING GEL, SKU: 22-3764, LOT: 19080020, WAS TESTED ON 05/14/2019, AND RESULTS WERE WITHIN SPECIFICATIONS. THIS LOT WAS THE MOST RECENT SHIPMENT SENT TO PARENT COMPANY. IN ADDITION, WE TESTED THE RETAIN SAMPLES OF OTHER LOTS PREVIOUSLY SENT TO THE PARENT COMPANY, SKU: 22-3764, LOT: 18271019, SKU: 22-3764, LOT: 18136009, SKU: 22-3764, LOT: 18194028, SKU: 22-3764, LOT: 18317011 AND RESULTS WERE WITHIN SPECIFICATIONS. THESE LOTS WERE STILL WITHIN EXPIRY DATE. REVIEWED THE DEVICE/BATCH HISTORY RECORDS OF WHITENING GEL, SKU: 22-3764, LOT: 19080020. NO OUT OF SPECIFICATION OR DISCREPANCY WAS FOUND. REVIEWED COMPLAINTS HISTORY, NO SIMILAR INCIDENT WAS REPORTED FROM THE SAME LOT NUMBERS. REVIEWED COMPLAINTS HISTORY OF THE PAST 3 YEARS. THE RATE FOR SIMILAR INCIDENTS IS LOW. REVIEWED DIRECTION FOR USE OF THE KIT. THE DFU DESCRIBES STEPS FOR CANDIDATE QUALIFICATION, WARNINGS, INGREDIENTS, AND OTHER PRECAUTIONS. BASED ON THE INVESTIGATION RESULTS, IT CAN BE CONCLUDED THAT THERE WAS NO PRODUCT FAILURE OR MALFUNCTION. WE WILL CONTINUE TO MONITOR THE TREND. BASED ON THE INVESTIGATION RESULTS AND AVAILABLE INFORMATION, DISCUS DENTAL CONCLUDES THERE WAS NO MALFUNCTION OR FAILURE IN THE PRODUCT. THE CAUSE OF THE INCIDENT IS INCONCLUSIVE. NO FURTHER INVESTIGATION AND CORRECTIVE ACTIONS ARE NEEDED.

    Description of Event or Problem · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2019 IN WHICH THE DENTAL HYGIENIST CALLED IN AND SAID SHE HAD IN OFFICE ZOOM WHITENING PROCEDURE ON (B)(6) 2019. THE PATIENT HAD GINGIVAL BLEEDING AND WAS REFERRED TO EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471408 PHILIPS ZOOM ZOOM CHAIRSIDE KIT EEG DISCUS DENTAL, LLC ZM2665 15225011

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization