MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-02 for EQUATE MTH GD RST ASRD W/TRAY 2CT MTH GD RST ASRD W/TRAY 2CT CD manufactured by Ranir Llc.
[116058455]
Consumer stated that the eq ex comft ngt gd caused her to get fine bumps on her lips and experience some irration. No medical attention was sought as yet. Update: 7. 11. 2018 after using it for a couple nights, the left side of her lip had started to break out and her teeth were sore. When she woke up the next morning her lip was swollen and broken out. Specifically bottom left lip. It is starting to go away and scab over, teeth are no longer sore since she stopped use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2018-00377 |
| MDR Report Key | 7744777 |
| Date Received | 2018-08-02 |
| Date of Report | 2018-08-02 |
| Date of Event | 2018-07-06 |
| Date Facility Aware | 2018-07-06 |
| Date Mfgr Received | 2018-07-06 |
| Date Added to Maude | 2018-08-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2018-08-02 |
| Model Number | MTH GD RST ASRD W/TRAY 2CT CD |
| Lot Number | 222388A |
| 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 |
|---|---|---|---|
| 0 | 0 | 2018-08-02 |