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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DISCUS DENTAL, LLC ZOOM WHITENING LAMP AND PROCEDURE KIT

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DISCUS DENTAL, LLC ZOOM WHITENING LAMP AND PROCEDURE KIT Back to Search Results
Model Number ZM2604P
Event Date 05/31/2010
Event Type  Other  
Event Description

The pt had the procedure on (b)(6) 2010 and came back to dr. (b)(6)'s office on (b)(6) 2010 complaining of a burning sensation in the upper and lower lips and a burning sensation/pain in right buccal and lingual (gums). Dr lyew prescribed 400 mg iodine. Later that evening, the pt went to the emergency room claiming she could not breathe due to swelling of her lips. The emergency room personnel (dr. ) prescribed pregnazone, vicodin and clendamidacine. Dr. (b)(6) did not report this incident to discus dental until (b)(6) 2010.

 
Manufacturer Narrative

The discus technical specialist for zoom chairside whitening (trevor rucker) investigated the incident and evaluated the process/procedure(s) that dr. (b)(6)'s office used in whitening the pt's teeth. It was strongly recommended that the dfu for the whitening procedure be followed. It could not be determined by interview as to why the lips were swollen with blisters, since proper procedure and materials were used as directed; however, the gum irritation and sensitivity may have occurred because the barrier material was applied too thick, possibly resulting in some high heat to the gums when the uv light was activated. The dfu was reviewed to make sure it contained best practice techniques to avoid uv exposure to the gums as well as initial training and follow-up training recommendations.

 
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Brand NameZOOM WHITENING LAMP AND PROCEDURE KIT
Manufacturer (Section D)
DISCUS DENTAL, LLC
culver city CA
Manufacturer Contact
8550 higuera st
culver city , CA 90232
3108458336
MDR Report Key1785066
Report Number2032714-2010-00003
Device Sequence Number1
Product CodeEEG
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation DENTIST
Remedial Action Other
Type of Report Initial
Report Date 07/09/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/15/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberZM2604P
Device Catalogue NumberZM2604P
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/09/2010
Distributor Facility Aware Date05/31/2010
Event Location Other
Date Manufacturer Received06/09/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/22/2010
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 07/15/2010 Patient Sequence Number: 1
Treatment
ZOOM WHITENING PROCEDURE KIT 25%
(B)(4)
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