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 2018-08-09 for CLEAR-LOCK RETAINERS FOR LIFE NI manufactured by Prismatik Dentalcraft, Inc..
[116702739]
Date of event was not specified; however, the patient used reported device some time in between (b)(6) 2018 to (b)(6) 2018. The device was received and the evaluation is anticipated. Once the investigation is completed, a supplemental report will be submitted. This report is for the 2nd of 6 reported devices for the same patient: please reference 3011649314-2018-00264 ((b)(4)) for the 1st device. Please reference 3011649314-2018-00266 ((b)(4)) for the 3rd device. Please reference 3011649314-2018-00267 ((b)(4)) for the 4th device. Please reference 3011649314-2018-00268 ((b)(4)) for the 5th device. Please reference 3011649314-2018-00269 ((b)(4)) for the 6th device.
Patient Sequence No: 1, Text Type: N, H10
[116702740]
This report is for the 1st lower retainer: it was reported that the patient experienced adverse reaction while using the clear lock retainer appliances. The patient reported of erythema on the area near tooth # 12 and # 13 and the right lateral area of the tongue. The patient also reported of burning sensation at tip of the tongue. The patient tried over the counter alcohol free mouth wash and hydrogen peroxide with no change in symptoms. The patient requested antiviral medication as symptoms were similar to her previous viral outbreak in the past. Valtrex was prescribed but it made her sick. Xylocaine was also prescribed, which only helped for an hour at a time. The patient experienced irritation with retainers since she began to use the devices in (b)(6) 2018 to (b)(6) 2018. The patient stopped using the devices in (b)(6) 2018 when there was no change to the patient's symptoms. The dentist made adjustment to the upper retainers to move away from the tissue on the palate on the upper left. Patient was recommended to clean the retainers using warm water and soft toothbrush. The patient has no known allergies; however, the patient has had dry mouth at night occasionally for years. The patient reported to be taking several medications: sertraline 25mg for years, crestor 5mg, baby aspirin 82mg and nutrafol supplements (4 tabs per day).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2018-00265 |
| MDR Report Key | 7770827 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-09 |
| Date of Report | 2018-11-08 |
| Date Mfgr Received | 2018-11-08 |
| Device Manufacturer Date | 2018-03-10 |
| Date Added to Maude | 2018-08-09 |
| 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 | 3 |
| Brand Name | CLEAR-LOCK RETAINERS FOR LIFE |
| Generic Name | RETAINER |
| Product Code | DYJ |
| Date Received | 2018-08-09 |
| Returned To Mfg | 2018-07-11 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other; 2. Required No Informationntervention | 2018-08-09 |