OCCLUDE ARTICULATION SPRAY 05300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-05-22 for OCCLUDE ARTICULATION SPRAY 05300 manufactured by Pascal Co., Inc..

Event Text Entries

[2639357] The pt contacted our office reporting an adverse reaction to our product, occlude articulation spray. Symptoms included cough and tickle in the throat at the tie of the dental procedure. During the course of the following few weeks since the date of event the pt experienced disorientation, loss of appetite, swelling of airway, difficulty breathing, chest pains, swollen liver, and hyperthyroidism. The pt was requesting a list of ingredients to determine what, if any, could have caused these symptoms. The pt went to the hospital emergency room. It was unclear from the pt what treatment she received, or the full extent of any tests performed. One test that she said was performed was for liver enzymes, which were reported to be very high. The pt refused to supply the name of the dentist or the clinic. She stated that she wanted to wait until the dentist completed the procedure before he became informed of her inquiries. The pt sought medical attention after the emergency visit. The physician informed her that she had been "poisoned" and required detoxification measures. The physician administered an intravenous vitamin c and glutathione over the course of several weeks. On (b)(6), the pt provided the name of the dentist. I contacted the clinic and was told by the rep that the pt gave expressed instructions not to divulge any info; that the pt wanted to be the sole provider of info. The rep informed me that the clinic gave the pt the unit of occlude for her to conduct allergy tests. I contacted the pt requesting the lot number, but was unsuccessful in obtaining it. The clinic said that the pt had provided the clinic a list of approved drugs for any procedures. The pt said that she was allergic to certain dyes, and has a general sensitivity to many chemicals. She said that she suspected the propellant, isobutane, was the cause of her symptoms.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011632-2012-00002
MDR Report Key2588148
Report Source07
Date Received2012-05-22
Date of Report2012-05-21
Date of Event2012-02-09
Date Mfgr Received2012-04-11
Date Added to Maude2012-05-29
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 ContactVINCENT TENTARELLI
Manufacturer Street2929 N.E. NORTHUP WAY
Manufacturer CityBELLEVUE WA 98004
Manufacturer CountryUS
Manufacturer Postal98004
Manufacturer Phone4256023633
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOCCLUDE ARTICULATION SPRAY
Generic NameDENTAL ARTICULATION SPRAY
Product CodeEFH
Date Received2012-05-22
Model NumberNA
Catalog Number05300
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPASCAL CO., INC.
Manufacturer AddressBELLEVUE WA 98004 US 98004


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2012-05-22

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