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 2019-05-21 for ASTRON CLEARSPLINTS NI manufactured by Prismatik Dentalcraft, Inc..
[145744751]
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.
Patient Sequence No: 1, Text Type: N, H10
[145744752]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2019-00165 |
| MDR Report Key | 8630261 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-21 |
| Date of Report | 2019-11-06 |
| Date of Event | 2019-04-12 |
| Date Mfgr Received | 2019-10-17 |
| Device Manufacturer Date | 2019-04-09 |
| Date Added to Maude | 2019-05-21 |
| 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 | MRS. ANDREA HUNTER |
| Manufacturer Street | 2212 DUPONT DRIVE SUITE P |
| Manufacturer City | IRVINE 92612 |
| Manufacturer Country | US |
| Manufacturer Postal | 92612 |
| Manufacturer Phone | 9494402635 |
| Manufacturer G1 | PRISMATIK DENTALCRAFT, INC. |
| Manufacturer Street | 2212 DUPONT DRIVE SUITE P |
| Manufacturer City | IRVINE 92612 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92612 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASTRON CLEARSPLINTS |
| Generic Name | MOUTHGUARD, ASTRON SPLINT |
| Product Code | MQC |
| Date Received | 2019-05-21 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 92612 US 92612 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-21 |