PHILIPS ZOOM 881055601540

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-09-21 for PHILIPS ZOOM 881055601540 manufactured by Discus Dental, Llc.

Event Text Entries

[121436097] Discus dental received a complaint on (b)(4) 2018, in which the patients face began to swell after a zoom chairside whitening procedure. The patient also developed numbness and swelling of her lower lip. The patient went to urgent care and was given dexamethasone injection, 3 doses of benadryl and was prescribed 20mlg prednisone. 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: 18165002, was tested on 08/31/2018, and results were within specifications. Reviewed the device/batch history records of whitening kit, sku: 881055601540, lot: 18165003 and gel, sku: 22-3764, lot: 18165002. No out of specification or discrepancy was found. Reviewed complaints history, no other 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. All ingredients are listed on labeling. No product failure or out of specifications was found in the product. Potential cause may be an allergic reaction to product ingredients. 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. Patient is doing much better, the swelling is gone and she is fine.
Patient Sequence No: 1, Text Type: N, H10


[121436098] Discus dental received a complaint on (b)(4) 2018, in which the patients face began to swell after a zoom chairside whitening procedure. The patient also developed numbness and swelling of her lower lip. The patient went to urgent care and was given dexamethasone injection, 3 doses of benadryl and was prescribed 20mlg prednisone.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1000582314-2018-00005
MDR Report Key7900055
Report SourceHEALTH PROFESSIONAL
Date Received2018-09-21
Date of Report2018-09-21
Date of Event2018-08-29
Date Mfgr Received2018-08-29
Device Manufacturer Date2018-06-14
Date Added to Maude2018-09-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactFRANCES ESTRADA
Manufacturer Street1700A SOUTH BAKER AVE.
Manufacturer CityONTARIO CA 91761
Manufacturer CountryUS
Manufacturer Postal91761
Manufacturer Phone9095703542
Manufacturer G1DISCUS DENTAL, LLC
Manufacturer Street1700 A SOUTH BAKER AVE
Manufacturer CityONTARIO CA 91761
Manufacturer CountryUS
Manufacturer Postal Code91761
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePHILIPS ZOOM
Generic NameZOOM CHAIRSIDE KIT
Product CodeEEG
Date Received2018-09-21
Model Number881055601540
Lot Number18165003
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDISCUS DENTAL, LLC
Manufacturer Address1700A SOUTH BAKER AVE. ONTARIO CA 91761 US 91761


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-09-21

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