MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for UP&UP MTH GD RST ASRD W/TRAY 2CT MTH GD RST ASRD W/TRAY 2CT CD manufactured by Ranir Llc.
[125614607]
Consumer purchased night guard 2ct - up&up. Consumer said pieces of it is coming off and if swallowed guest would like to know if the materials this is made out of can be harmful or not. Store clerk resolved with consumer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2018-00440 |
| MDR Report Key | 8019272 |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-30 |
| Date of Event | 2018-09-19 |
| Date Facility Aware | 2018-10-16 |
| Date Mfgr Received | 2018-10-16 |
| Date Added to Maude | 2018-10-30 |
| 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 |
| Generic Name | MOUTHGUARD, OVER-THE-COUNTER |
| Product Code | OBR |
| Date Received | 2018-10-30 |
| 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 | 2018-10-30 |