CLEAR-LOCK RETAINERS FOR LIFE NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-04-06 for CLEAR-LOCK RETAINERS FOR LIFE NI manufactured by Prismatik Dentalcraft, Inc..

Event Text Entries

[104660089] (b)(4). Follow-up attempts were made to request to have the devices back; however, the devices have not been returned as of late. Additional follow-up will be done to request for the devices. Once the evaluation is completed, a supplemental report will be submitted. This is report for the 1st of 2 devices that patient used. Please reference 3011649314-2018-00088 ((b)(4)) for the 1st event of the 1st device. Please reference 3011649314-2018-00086 ((b)(4)) for the report of the 2nd device.
Patient Sequence No: 1, Text Type: N, H10


[104660090] This complaint is for the 2nd event (2nd day): it was reported that the patient experienced an allergic reaction while using clear-lock retainer and comfort splint. On the day of delivery clear-lock retainer and comfort splint, the patient felt irritation on the inside of the cheek and lips after wearing the retainer for 3-4 hours. On the first night, the patient wore the retainer together with the splint. Upon waking up the next day, the patient felt disoriented. After removing the splint and the retainer, the patient started feeling better as the day went on. The patient wore the retainer again that night without the splint and started feeling "clogging up". The patient reported of face swelling and throat was closing up with difficulty breathing and itching. The patient discontinued using the retainer on that night. At 3:00 am, the patient still felt bad and decided to go to the er. The patient had an iv line, had blood work done, and was given benadryl. The patient was released in the morning with a prescription of steroids and benadryl. In the next 3-4 days, the patient felt like her entire gastrointestinal tract was inflamed. The patient reported of sores in the mouth and could not eat. The patient also reported of skin peeling. After 5 days, the patient's symptoms improved and felt like she was "back to normal". For relevant dental history, the patient has temporomandibular dysfunction with orthodontic relapse. For relevant medical history, the patient had facial trauma which required surgery. Since the trauma, she has had difficulty with her maxillary sinuses "getting clogged". The patient has seasonal hay fever allergies. The patient is taking montelukast na 10mg and 2 nyquil at bedtime to allow sinus drainage. An occlusion adjustment was made to the comfort splint by the dentist. It was cleaned with isopropyl alcohol to remove ink marking and rinsed with water before delivering to the patient. The patient was instructed to clean the device using only brush and water. The patient has fully recovered.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011649314-2018-00089
MDR Report Key7405340
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-04-06
Date of Report2018-07-06
Date of Event2018-03-06
Date Mfgr Received2018-07-06
Device Manufacturer Date2018-02-28
Date Added to Maude2018-04-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. TOAN HOANG
Manufacturer Street2212 DUPONT DRIVE SUITE P
Manufacturer CityIRVINE CA 92612
Manufacturer CountryUS
Manufacturer Postal92612
Manufacturer Phone9492251235
Manufacturer G1PRISMATIK DENTALCRAFT, INC.
Manufacturer Street2212 DUPONT DRIVE SUITE P
Manufacturer CityIRVINE CA 92612
Manufacturer CountryUS
Manufacturer Postal Code92612
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLEAR-LOCK RETAINERS FOR LIFE
Generic NameRETAINER
Product CodeDYJ
Date Received2018-04-06
Model NumberNI
Catalog NumberNI
Lot NumberNI
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPRISMATIK DENTALCRAFT, INC.
Manufacturer Address2212 DUPONT DRIVE SUITE P IRVINE CA 92612 US 92612


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention 2018-04-06

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