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 2019-05-14 for COMFORT HARD-SOFT BITE SPLINT NI manufactured by Prismatik Dentalcraft, Inc..
[145077141]
Patient's weight was asked but unknown. Follow-ups were made to request for more information on the event; however, only some information have been provided. Request was also made to have product return, but the patient has not returned the mouthguard back to the clinic yet. Once the evaluation is completed and new information is obtained, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[145077142]
It was reported that a patient experienced an allergic reaction after using a comfort hard-soft bite splint. After using the mouthguard for the first time, the patient developed sores at the tip of her tongue and on the upper lip. Upon experiencing the reaction, the patient stopped using the mouthguard and the symptoms went away. The patient has no known pre-existing condition or allergy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2019-00150 |
| MDR Report Key | 8610382 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-14 |
| Date of Report | 2019-08-14 |
| Date Mfgr Received | 2019-08-13 |
| Device Manufacturer Date | 2019-02-14 |
| Date Added to Maude | 2019-05-14 |
| 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 | COMFORT HARD-SOFT BITE SPLINT |
| Generic Name | THERMOFORMED MOUTHGUARD, COMFORT SPLINTS |
| Product Code | MQC |
| Date Received | 2019-05-14 |
| 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 CA 92612 US 92612 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-14 |