FDA.reportPublic FDA data

MAUDE MDR 8630261

MDR report key
8630261
Report number
3011649314-2019-00165
Event key
0
Event type
3
Date of event
2019-04-12
Date received
2019-05-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. ANDREA HUNTER
Address
2212 DUPONT DRIVE SUITE P IRVINE 92612 US
Phone
949-949-9494
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ASTRON CLEARSPLINTSMOUTHGUARD, ASTRON SPLINTPRISMATIK DENTALCRAFT, INC.MQCNININIY N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-2101. O

Event Narratives#

N

Patient 1

PATIENT'S DATE OF BIRTH WAS ASKED BUT WAS NOT PROVIDED. REQUEST WAS MADE TO HAVE THE MOUTHGUARD RETURN FOR EVALUATION; HOWEVER, THE PATIENT DECIDED TO KEEP THE MOUTHGUARD FOR NOW. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS FOR THE 2ND OF USING THE MOUTHGUARD. PLEASE REFERENCE 3011649314-2019-00164 ((B)(4)) FOR THE 1ST NIGHT.

D

Patient 1

THIS REPORT IS FOR THE 2ND NIGHT OF USING THE MOUTHGUARD: IT WAS REPORTED THAT A PATIENT EXPERIENCED ALLERGIC REACTION AFTER WEARING THE ASTRON CLEARSPLINT MOUTHGUARD OVERNIGHT. ON THE FIRST NIGHT, THE PATIENT HAD EXCESSIVE SALIVATION IMMEDIATELY AFTER PLACING THE MOUTHGUARD INTO HIS MOUTH. AFTER 1-2 MINUTES, THE PATIENT'S TONGUE HAD A BURNING FEELING, NUMBNESS, REDNESS AND MINOR SWELLING IN THE AREA WHERE IT TOUCHED THE MOUTHGUARD. ON THE SECOND NIGHT OF USE, THE PATIENT EXPERIENCED A BURNING AND NUMBNESS FEELING. THE MOUTHGUARD WAS USED FOR 2 ENTIRE NIGHTS WITHOUT REMOVAL. THE PATIENT REPORTED THE SALIVATION EVENTUALLY DECREASED. AFTER 72 HOURS OF NOT WEARING THE MOUTHGUARD, THE PATIENT'S TONGUE RETURNED TO NORMAL. THE PATIENT DID NOT REQUIRE ANY TREATMENT FOR THE REACTION. THE PATIENT HAS NO PRE-EXISTING CONDITIONS OR ALLERGIES. THE PATIENT REPORTED THAT HE PLACED THE MOUTHGUARD IN THE MOUTH BEFORE CLEANING OR RINSING IT. AFTER USE ON THE SECOND NIGHT THE PATIENT CLEANED THE MOUTHGUARD USING ONLY A TOOTHBRUSH AND WATER. THE PATIENT DID NOT WANT THE DENTAL OFFICE TO RETURN THE MOUTHGUARD AS HE INSISTED ON USING THE ASTRON MOUTHGUARD AGAIN. TO DATE, IT IS UNKNOWN IF THE PATIENT HAS USED THE MOUTHGUARD AGAIN; HOWEVER, THERE HAVE BEEN NO REPORTED ADVERSE REACTION.