MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-30 for COMFORT HARD BITE SPLINT NI manufactured by Prismatik Dentalcraft, Inc..
[146628370]
The device was received and the evaluation is anticipated, however not yet begun. Once the evaluation is completed, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[146628371]
It was reported that the patient experienced an allergic reaction after wearing a mouthguard for "a couple of days. " the patient experienced "what felt like sores all over my mouth and my tongue and had raw spots along the edges. " the patient kept wearing the device for over a week to see if the reaction would get better; however, it did not. The reaction resolved and the patient's mouth healed after "about 10 days. " patient has allergies to latex, bananas, and sulfa antibiotics. The patient has no relevant pre-existing conditions. The mouthguard did not have any adjustments made to it and it was cleaned with warm water prior to delivery to the patient. The event date is unknown, per received information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2019-00171 |
| MDR Report Key | 8656779 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-30 |
| Date of Report | 2019-09-19 |
| Date Mfgr Received | 2019-08-22 |
| Device Manufacturer Date | 2019-02-12 |
| Date Added to Maude | 2019-05-30 |
| 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 CA 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 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 BITE SPLINT |
| Generic Name | COMFORT HARD BITE SPLINT |
| Product Code | MQC |
| Date Received | 2019-05-30 |
| Returned To Mfg | 2019-05-28 |
| 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 IRVINE CA 92612 US 92612 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-30 |