RETRACTION ALL TYPES 40005202

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2012-10-03 for RETRACTION ALL TYPES 40005202 manufactured by Ultradent Products, Inc..

Event Text Entries

[15152952] (b)(6) called because she wanted an ingredient list for vw max and gingival battier. She said that dr (b)(6) daughter went to another office for whitening. She said that they are an orthodontic office, but her friend a fellow orthodontist does the in-office whitening. The pt went to the office and had the treatment on thursday. I asked to get the other office info. She said that they did not want to provide this info. She said that she had asked and that they had applied the barrier, light cured, had placed the standard ortho cheek retractors. Then they proceeded with the whitening. They did 2 to 3, 12 - 15 minute applications, rinsed and used a standard ortho evacuation tip to suction. She said that there was some haloing of the gingiva upon removal of the gingival barrier. She said that they generally see this, and the pt was informed and told that it would disappear by morning. She said that on the morning of (b)(6) 2012, the pt woke up with swollen, red, bleeding gums. She said the gingiva was bleeding on the maxillary and mandibular from first molar to first molar. She saw a physician who said that it appeared to be an allergic reaction. She has not been able to comfortably eat due to the extreme inflammation of her gums. She has impeccable oral hygiene and normally very healthy gum tissue. She has been taking benadryl since friday evening. She said that the pt has been doing warm salt water rinses 2 times a day. She said that she will remain on the benadryl until we can provide further info before consulting with other medical practitioner. She said that the pt has not noticed any tooth sensitivity. I advised that the pt see an allergist and said that i would send a vw max kit for testing. She asked if we could send a take home kit for testing as the pt wants to try this if possible and would like to take this to the allergist also.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1718912-2012-00004
MDR Report Key2795017
Report Source05,08
Date Received2012-10-03
Date of Report2012-10-03
Date of Event2012-08-24
Date Mfgr Received2012-08-29
Date Added to Maude2012-11-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street10200 S 505 W
Manufacturer CitySOUTH JORDAN UT 84905
Manufacturer CountryUS
Manufacturer Postal84905
Manufacturer Phone8005525512
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRETRACTION ALL TYPES
Generic NameLIGHT CURED RESIN BARRIERS
Product CodeEJK
Date Received2012-10-03
Model Number40005202
Catalog Number40005202
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerULTRADENT PRODUCTS, INC.
Manufacturer AddressSOUTH JORDAN UT US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2012-10-03

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