MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-09 for REXALL MTH GD RST ASRD W/TRAY CRTN manufactured by Ranir Llc.
[178751030]
Consumer bought the rest assured extra comfort and it? S not fitting her right. It? S very weak and thin at the front so part of it is breaking off already. She wants a replacement. Consumer threw guard away.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2020-00685 |
| MDR Report Key | 9569326 |
| Report Source | CONSUMER |
| Date Received | 2020-01-09 |
| Date of Report | 2020-01-09 |
| Date of Event | 2019-12-16 |
| Date Facility Aware | 2019-12-16 |
| Date Mfgr Received | 2019-12-16 |
| Date Added to Maude | 2020-01-09 |
| 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 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 | REXALL |
| Generic Name | MOUTHGUARD, OVER-THE-COUNTER |
| Product Code | OBR |
| Date Received | 2020-01-09 |
| Model Number | MTH GD RST ASRD W/TRAY CRTN |
| Lot Number | 264891C |
| 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 | 2020-01-09 |