BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 7111519 · Received December 12, 2017

    Report

    Report Number
    1000582314-2017-00010
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    November 17, 2017
    Report Date
    December 12, 2017
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    UDI-DI
    00075020065780
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(4) 2017 IN WHICH THE DENTAL OFFICE MANAGER REPORTED THAT THE GEL FROM TAKE HOME TEETH WHITENING SYRINGE GOT INTO HIS EYE WHEN HE WAS CLOSING THE SYRINGE. HE RINSED HIS EYE WITH WATER, AND SINCE THE EYE WAS STILL RED AFTER THE INCIDENT HE VISITED A DOCTOR. HE RESPONDED LATER THE SAME DAY THAT HE IS OK. INVESTIGATION: THE RETAIN SAMPLE OF THE TAKE HOME WHITENING GEL, SKU: (B)(4), LOT: 17279015 WAS TESTED ON 11/21/2017 AND RESULTS WERE WITHIN SPECIFICATIONS. REVIEWED DEVICE HISTORY RECORDS OF ZOOM WHITENING KIT, SKU: (B)(4), LOT: 17299012, AND TAKE HOME WHITENING GEL, SKU: (B)(4), LOT: 17279015 AND NO OUT OF SPECIFICATION OR DISCREPANCY WAS FOUND IN THE RECORDS. REVIEWED COMPLAINTS HISTORY, NO OTHER SIMILAR INCIDENTS WERE REPORTED SINCE JANUARY 2015. NO OTHER SIMILAR INCIDENT WAS REPORTED FROM ALL FINISHED KITS THAT TAKE HOME WHITENING GEL, SKU: (B)(4), LOT: 17279015 WAS USED. BASED ON THE INVESTIGATION RESULTS AND AVAILABLE INFORMATION, IT CAN BE CONCLUDED THAT THERE WAS NO FAILURE AND MALFUNCTION IN THE DEVICE. POTENTIAL CAUSE WILL BE USER ERROR AND APPLYING PRESSURE TO THE PLUNGER WHEN CLOSING THE SYRINGE CAP. ZOOM TAKE HOME DFU IS ADEQUATE AND IT DESCRIBES THE WARNINGS AND PRECAUTIONS WHEN HANDLING THE TAKE HOME SYRINGE (SECTION 4), AND FIRST AID INSTRUCTIONS IF GEL GETS INTO EYES (SECTION 5). " WARNINGS: REMOVE CAP SAFELY, CONTENTS MAY BE UNDER PRESSURE. RISK OF SERIOUS DAMAGE TO THE EYES. FIRST AID INSTRUCTIONS: ... IF HYDROGEN PEROXIDE (HP) OR CARBAMIDE PEROXIDE (CP) GEL GETS INTO EYES, ON SKIN OR HAIR, FLUSH WITH RUNNING WATER." BASED ON THE INVESTIGATION RESULTS, NO PRODUCT FAILURE AND OUT OF SPECIFICATION WAS FOUND. DFU IS ADEQUATE AND NO CORRECTIVE ACTION IS NEEDED.

    Description of Event or Problem · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(4) 2017 IN WHICH THE DENTAL OFFICE MANAGER REPORTED THAT THE GEL FROM TAKE HOME TEETH WHITENING SYRINGE GOT INTO HIS EYE WHEN HE WAS CLOSING THE SYRINGE. HE RINSED HIS EYE WITH WATER, AND SINCE THE EYE WAS STILL RED AFTER THE INCIDENT (NO BURNING), HE VISITED A DOCTOR. HE RESPONDED LATER THE SAME DAY THAT HE IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888026 PHILIPS ZOOM ZOOM CHAIRSIDE WHITENING KIT EEG DISCUS DENTAL, LLC 881055701540 17299012 00075020065780

    Patients

    Seq Age Sex Outcome Treatment
    1 Other