MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-03-04 for PLACKERS MTH GD GNM MTH GD GNM 10CT manufactured by Ranir Llc.
[137718516]
Consumer stated she had been a long time consumer of your grind no more night guards. She enjoyed using the guard as it's so much smaller and lighter than the big, full-coverage night guard. Consumer stated "it wasn't until recently that i learned i now have a malocclusion as a result of long-time use of grind no more. My back teeth no longer touch at exactly where the bite plates touch the teeth, thereby causing my front teeth to wear away and cause continuous chipping of that front-tooth bonding i have. At the suggestion of my dentist, i had an orthodontic consultation and 12-18 months worth of treatment to fix my problem. I'm sad that i wasn't aware that long-term use of your product would cause such major issues. She used the guards for 5 years (it was not clear if she was using the same exact guard, but it's believed that she was using several guards over the 5 years). Directions state not to use the product more than 3 months from initial use without consulting your dentist and to continue seeing your dentist every six months thereafter while using the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2019-00517 |
| MDR Report Key | 8386369 |
| Report Source | CONSUMER |
| Date Received | 2019-03-04 |
| Date of Report | 2019-03-04 |
| Date of Event | 2019-02-08 |
| Date Facility Aware | 2019-02-08 |
| Date Mfgr Received | 2019-02-08 |
| Date Added to Maude | 2019-03-04 |
| 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 MTH GD GNM |
| Generic Name | MOUTHGUARD, OVER-THE-COUNTER |
| Product Code | OBR |
| Date Received | 2019-03-04 |
| Model Number | MTH GD GNM 10CT |
| 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 | 2019-03-04 |