MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-28 for PLACKERS STOP GRINDING 1CT manufactured by Ranir Llc.
[146277258]
Consumer has been using the stop grinding guard for a number of years. Her teeth now don't touch, it's been like this for a year. She went to the dentist recently because she was trying to find a way to fix the problem. They sent her to the orthodontist. They asked her what her routine was and they said it was because of the guard she was using. They said the only way to fix it is to grind her teeth until they touch or she needs to get braces. She is asking for us to pay for braces. Labeling on the product indicates not to use the guard for more than 3 months from initial use without consulting your dentist. Consumer indicated that she was going to the dentist regularly but didn't state that she consulted with the dentist about the guard.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2019-00566 |
| MDR Report Key | 8647276 |
| Report Source | CONSUMER |
| Date Received | 2019-05-28 |
| Date of Report | 2019-05-28 |
| Date of Event | 2019-05-07 |
| Date Facility Aware | 2019-05-07 |
| Date Mfgr Received | 2019-05-07 |
| Date Added to Maude | 2019-05-28 |
| 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 | 3 |
| Brand Name | PLACKERS STOP GRINDING 1CT |
| Generic Name | MOUTHGUARD, OVER-THE-COUNTER |
| Product Code | OBR |
| Date Received | 2019-05-28 |
| Model Number | STOP GRINDING 1CT |
| 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 | 2019-05-28 |