MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-22 for RITE AID MTH GD RST ASRD W/TRAY 2CT CRTN manufactured by Ranir Llc.
[108996889]
Consumer stated she bought the night protector at (b)(6) and she tried both of the package. The first one fit beautifully for the first week, but then felt too big. I actually woke up one night and it was half way down my throat, gagging on it, she had to sit up and pull it out of her throat.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2018-00327 |
| MDR Report Key | 7531805 |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-21 |
| Date of Event | 2018-04-30 |
| Date Facility Aware | 2018-05-04 |
| Date Mfgr Received | 2018-05-04 |
| Date Added to Maude | 2018-05-22 |
| 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 | RITE AID MTH GD RST ASRD W/TRAY 2CT CRTN |
| Generic Name | MOUTHGUARD, OVER-THE-COUNTER |
| Product Code | OBR |
| Date Received | 2018-05-22 |
| Returned To Mfg | 2018-05-10 |
| Model Number | MTH GD RST ASRD W/TRAY 2CT CRTN |
| 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 | 2018-05-22 |