MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-21 for EQUATE MTH GD RST ASRD W/TRAY 2CT CD manufactured by Ranir Llc.
[131375463]
Reporter/patient stated that the eq ex comft ngt gd made her throat tighten down and her eyes started to water update: she wore the guard the first night and everything was ok. On the second night her eyes were watering and she started cough and her throat started to close up. It took about two days for her throat to return to normal. She had to use her inhaler multiple times. She believes she was having a reaction to elvax because she had a reaction to dentex a few months earlier. She has a very tight neck (stenosis), had surgery a few years ago and when her neck is bothering her she tends to grind more at night. She used to have a guard from the dentist but no longer uses that due to grinding it down so badly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2018-00467 |
| MDR Report Key | 8189214 |
| Date Received | 2018-12-21 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-12-03 |
| Date Facility Aware | 2018-12-03 |
| Date Mfgr Received | 2018-12-03 |
| Date Added to Maude | 2018-12-21 |
| 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 |
| 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 |
| Generic Name | MOUTHGUARD, OVER-THE-COUNTER |
| Product Code | OBR |
| Date Received | 2018-12-21 |
| Model Number | MTH GD RST ASRD W/TRAY 2CT CD |
| Lot Number | 239540A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-12-21 |