MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-19 for UP&UP MTH GD RST ASRD W/TRAY 2CT CD manufactured by Ranir Llc.
[120975511]
Consumer stated after molding the protector the cotton tray caused an extra groove in the front of it and by taking it out of his/her mouth caused it to rip into two pieces.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2018-00416 |
| MDR Report Key | 7891339 |
| Date Received | 2018-09-19 |
| Date of Report | 2018-09-19 |
| Date of Event | 2018-08-16 |
| Date Facility Aware | 2018-09-11 |
| Date Mfgr Received | 2018-09-11 |
| 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 | 0 |
| Brand Name | UP&UP MTH GD RST ASRD W/TRAY 2CT CD |
| Generic Name | MOUTHGUARD, OVER-THE-COUNTER |
| Product Code | OBR |
| Date Received | 2018-09-19 |
| Model Number | MTH GD RST ASRD W/TRAY 2CT CD |
| 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 | 2018-09-19 |