MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-06 for CLEAR-LOCK RETAINERS FOR LIFE NI manufactured by Prismatik Dentalcraft, Inc..
[104662662]
Method code: (device not returned). 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 3011649314-2018-00089 (b)(4) for the 2nd 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
[104662663]
This complaint is for the 1st event (initial wear): 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
| Report Number | 3011649314-2018-00088 |
| MDR Report Key | 7405330 |
| Date Received | 2018-04-06 |
| Date of Report | 2018-07-06 |
| Date of Event | 2018-03-06 |
| Date Mfgr Received | 2018-07-06 |
| Device Manufacturer Date | 2018-02-28 |
| Date Added to Maude | 2018-04-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TOAN HOANG |
| Manufacturer Street | 2212 DUPONT DRIVE SUITE P |
| Manufacturer City | IRVINE CA 92612 |
| Manufacturer Country | US |
| Manufacturer Postal | 92612 |
| Manufacturer Phone | 9492251235 |
| Manufacturer G1 | PRISMATIK DENTALCRAFT, INC. |
| Manufacturer Street | 2212 DUPONT DRIVE SUITE P |
| Manufacturer City | IRVINE CA 92612 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92612 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CLEAR-LOCK RETAINERS FOR LIFE |
| Generic Name | RETAINER |
| Product Code | DYJ |
| Date Received | 2018-04-06 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRISMATIK DENTALCRAFT, INC. |
| Manufacturer Address | 2212 DUPONT DRIVE SUITE P IRVINE CA 92612 US 92612 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2018-04-06 |