BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 8318343 · Received February 7, 2019

    Report

    Report Number
    1000582314-2019-00001
    Event Type
    Injury
    Date Received
    February 7, 2019
    Date of Event
    January 16, 2019
    Report Date
    December 9, 2020
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ORIGINAL REPORT: DISCUS DENTAL RECEIVED A COMPLAINT ON 01/16/2019, IN WHICH THE PATIENT EXPERIENCED SEVERE PAIN AFTER THE THIRD SESSION OF THE INOFFICE CHAIRSIDE TEETH WHITENING PROCEDURE. OFFICE CALLED IN AND WAS ADVISED TO APPLY RELIEF ACP GEL FOR 30 MINUTES AND TAKE IBUPROFEN. OFFICE CALLED BACK SAYING THE PAIN DID NOT GO AWAY AND SEEMED TO BE WORSE. PAIN AND SENSITIVITY IS A COMMON SIDE EFFECT OF THE ZOOM IN-OFFICE CHAIRSIDE TEETH WHITENING PROCEDURE. HOWEVER, SINCE THE COSMETIC PROCEDURE USES ZOOM2 ADVANCED POWER LAMP (CLASS I DEVICE) AND RELIEF ACP (CLASS II DEVICE) WAS USED TO TREAT SENSITIVITY, THIS INCIDENT IS BEING REPORTED TO FDA. NO IMPACT ON SHIPPED PRODUCTS FROM THE SAME LOT AND NO SIMILAR COMPLAINT FROM THE LOT OF COSMETIC GEL. NO CONTAINMENT ACTION IS REQUIRED. THE KIT AND GEL WERE USED UP DURING THE PROCEDURE AND WERE NOT RETURNED. THE RETAIN SAMPLE OF THE TEETH WHITENING GEL, SKU: 22-3764, LOT: 18165002, WAS TESTED ON 01/17/2019, AND RESULTS WERE WITHIN SPECIFICATIONS. REVIEWED THE DEVICE/BATCH HISTORY RECORDS OF ZOOM' TEETH WHITENING KIT, SKU: 881 055601 540. LOT: 18165003 AND GEL, SKU: 22-3764, LOT: 18165002. NO OUT OF SPECIFICATION OR DISCREPANCY WAS FOUND. REVIEWED DEVIATION AND NCMR RECORDS OF ZOORN2 ADVANCED POWER LAMP AND NO OUT OF SPECIFICATION OR DISCREPANCY WAS FOUND. 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, TREATMENT FOR SENSITIVITY AND OTHER PRECAUTIONS. NO PRODUCT FAILURE OR OUT OF SPECIFICATIONS WAS FOUND IN THE PRODUCT. POTENTIAL CAUSE MAY BE DUE TO A PRE-EXISTING SENSITIVITY. 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. FOLLOW UP REPORT: ADDED UDI NUMBER (B)(4) AND LAMP INFORMATION ZM2564 SERIAL NUMBER (B)(6).

    Description of Event or Problem · 0

    DISCUS DENTAL RECEIVED A COMPLAINT ON 01/16/2019, IN WHICH THE PATIENT EXPERIENCED SEVERE PAIN AFTER THE THIRD SESSION OF THE IN-OFFICE CHAIRSIDE TEETH WHITENING PROCEDURE. OFFICE CALLED IN AND WAS ADVISED TO APPLY RELIEF ACP GEL FOR 30 MINUTES AND TAKE IBUPROFEN. OFFICE CALLED BACK SAYING THE PAIN DID NOT GO AWAY AND SEEMED TO BE WORSE.

    Additional Manufacturer Narrative · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2019, IN WHICH THE PATIENT EXPERIENCED SEVERE PAIN AFTER THE THIRD SESSION OF THE IN-OFFICE CHAIRSIDE TEETH WHITENING PROCEDURE. OFFICE CALLED IN AND WAS ADVISED TO APPLY RELIEF ACP GEL FOR 30 MINUTES AND TAKE IBUPROFEN. OFFICE CALLED BACK SAYING THE PAIN DID NOT GO AWAY AND SEEMED TO BE WORSE. PAIN AND SENSITIVITY IS A COMMON SIDE EFFECT OF THE ZOOM IN-OFFICE CHAIRSIDE TEETH WHITENING PROCEDURE. HOWEVER, SINCE THE COSMETIC PROCEDURE USES ZOOM2 ADVANCED POWER LAMP (CLASS I DEVICE) AND RELIEF ACP (CLASS II DEVICE) WAS USED TO TREAT SENSITIVITY, THIS INCIDENT IS BEING REPORTED TO FDA. NO IMPACT ON SHIPPED PRODUCTS FROM THE SAME LOT AND NO SIMILAR COMPLAINT FROM THE LOT OF COSMETIC GEL. NO CONTAINMENT ACTION IS REQUIRED. THE KIT AND GEL WERE USED UP DURING THE PROCEDURE AND WERE NOT RETURNED. THE RETAIN SAMPLE OF THE TEETH WHITENING GEL, SKU: 22-3764, LOT: 18165002, WAS TESTED ON 01/17/2019, AND RESULTS WERE WITHIN SPECIFICATIONS. REVIEWED THE DEVICE/BATCH HISTORY RECORDS OF ZOOM! TEETH WHITENING KIT, SKU: 881055601540, LOT: 18165003 AND GEL, SKU: 22-3764, LOT: 18165002. NO OUT OF SPECIFICATION OR DISCREPANCY WAS FOUND. REVIEWED DEVIATION AND NCMR RECORDS OF ZOOM2 ADVANCED POWER LAMP AND NO OUT OF SPECIFICATION OR DISCREPANCY WAS FOUND. 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, TREATMENT FOR SENSITIVITY AND OTHER PRECAUTIONS. NO PRODUCT FAILURE OR OUT OF SPECIFICATIONS WAS FOUND IN THE PRODUCT. POTENTIAL CAUSE MAY BE DUE TO A PRE-EXISTING SENSITIVITY. 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.

    Description of Event or Problem · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2019, IN WHICH THE PATIENT EXPERIENCED SEVERE PAIN AFTER THE THIRD SESSION OF THE IN-OFFICE TEETH WHITENING COSMETIC PROCEDURE. DENTAL OFFICE CALLED IN AND WAS ADVISED TO APPLY RELIEF ACP GEL FOR 30 MINUTES AND TAKE IBUPROFEN. OFFICE CALLED BACK SAYING THE PAIN DID NOT GO AWAY AND SEEMED TO BE WORSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108599 PHILIPS ZOOM ZOOM CHAIRSIDE KIT EEG DISCUS DENTAL, LLC 22-3764, ZM2564 AND 881055601540 18165002 & 18165003

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| O