MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-09-19 for LIFE BRAND MTH GD RST ASRD W/TRAY CRTN manufactured by Ranir Llc.
[120706890]
Consumer stated he purchased your grind guard from (b)(6). For 3 nights the pain increased more and more everyday. He had jaw pain, neck pain, ear pain and pain in his teeth. He stated that he is hoping the pain left behind from this product isn? T permanent because de doesn't have good insurance coverage. Please help me with this because its very hard to work and do everyday tasks when you are in this much pain (b)(6) 2018-consumer updated ranir that one of my teeth now feel lose as a result of the product and asked for the claims department.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2018-00414 |
| MDR Report Key | 7888807 |
| Report Source | CONSUMER |
| Date Received | 2018-09-19 |
| Date of Report | 2018-09-19 |
| Date of Event | 2018-08-21 |
| Date Facility Aware | 2018-08-21 |
| Date Mfgr Received | 2018-08-21 |
| Date Added to Maude | 2018-09-19 |
| 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 | 3 |
| Brand Name | LIFE BRAND MTH GD RST ASRD W/TRAY CRTN |
| Generic Name | MOUTHGUARD, OVER-THE-COUNTER |
| Product Code | OBR |
| Date Received | 2018-09-19 |
| Returned To Mfg | 2018-08-31 |
| Model Number | MTH GD RST ASRD W/TRAY CRTN |
| Lot Number | 220937A |
| 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 | 2018-09-19 |