MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-28 for EQUATE MTH GD RST ASRD W/TRAY 2CT MTH GD RST ASRD W/TRAY 2CT CD manufactured by Ranir Llc.
[128752491]
Consumer called in stating this eq ex comft ngt gd caused her jaw to lock. (b)(6) 2018 update; it was her first time wearing the guard, only had the guard in for about an hour. Once the guard was out, her jaw keeps locking up and clicking. Incident happened on (b)(6) 2018 and she is still experiencing some residual issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2018-00454 |
| MDR Report Key | 8110596 |
| Date Received | 2018-11-28 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-11-01 |
| Date Facility Aware | 2018-11-01 |
| Date Mfgr Received | 2018-11-01 |
| Date Added to Maude | 2018-11-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | REBEKAH STENSKE |
| Manufacturer Street | 4701 EAST PARIS AVE. SE |
| Manufacturer City | GRAND RAPIDS MI 495125353 |
| Manufacturer Country | US |
| Manufacturer Postal | 495125353 |
| Manufacturer Phone | 6166988880 |
| Manufacturer G1 | RANIR LLC |
| Manufacturer Street | 4701 EAST PARIS AVE. SE |
| Manufacturer City | GRAND RAPIDS MI 495125353 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 495125353 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EQUATE MTH GD RST ASRD W/TRAY 2CT |
| Generic Name | MOUTHGUARD, OVER-THE-COUNTER |
| Product Code | OBR |
| Date Received | 2018-11-28 |
| Returned To Mfg | 2018-11-16 |
| Model Number | MTH GD RST ASRD W/TRAY 2CT CD |
| Lot Number | 241300C |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RANIR LLC |
| Manufacturer Address | 4701 EAST PARIS AVE. SE GRAND RAPIDS MI 495125353 US 495125353 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-28 |