MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT INC. COMFORT HARD-SOFT BITE SPLIN; THERMOFORM MOUTHGUARD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); Nasal Obstruction (2466)

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned.An investigation will be conducted once the device/sample has been returned and a supplemental report will be submitted.Age - asked, but unknown.Date of birth - asked, but unknown.Weight- asked, but unknown.Ethnicity- asked, but unknown.Race - asked, but unknown.Date of event - asked, but unknown.Model number - not applicable.Catalog number - not applicable.Lot number - not applicable.Expiration date - not applicable.Udi number - not available.

Event Description

It was reported that a patient experienced an allergic reaction after using a comfort hard-soft bite splint (blue upper).According to the information provided by the doctor, the patient complained of a sore throat and excessive nasal drip shortly after appliance was delivered (unknown date).The doctor advised the patient to stop using the device and reaction went away in a few days.It is unknown whether or not the patient has any known allergies.

Manufacturer Narrative

The device was not returned for evaluation.A batch/lot review for the associated material showed no manufacturing deviations or abnormalities.Glidewell research team and namsa conducted a series of testing on erkodent material (erkoloc-pro and erkodur) following iso 10993 (biological evaluation of medical devices) and the device was evaluated for potential cytotoxicity, skin irritation, delayed dermal contact sensitization and oral mucosal irritation.The test results were listed and summarized in rpt 9733 rev 1.0.· for cytotoxicity testing, the test article extract showed no evidence of causing cell lysis or toxicity.· for skin irritation, there was no erythema and no edema observed on the skin test.· for sensitization testing, the test article extracts showed no evidence of causing delayed dermal contact sensitization.· the test article showed nonirritant to the oral mucosa as compared to the control article.This complaint will be kept on record for track and trending purposes.

• Brand Name: COMFORT HARD-SOFT BITE SPLIN
• Type of Device: THERMOFORM MOUTHGUARD
• Manufacturer (Section D): PRISMATIK DENTALCRAFT INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 8964566
• MDR Text Key: 156583439
• Report Number: 3011649314-2019-00500
• Device Sequence Number: 1
• Product Code: MQC
• Combination Product (y/n): N
• PMA/PMN Number: K121365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other