MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-28 for PLACKERS STOP GRINDING STOP GRINDING 1CT manufactured by Ranir Llc.
[138699969]
Consumer stated she swallowed the grind guard. She called to see if she needed to seek medical attention. She swallowed with 10 pills at the same time, she forgot the guard was in her mouth and she believes she swallowed the guard when she swallowed the pills. Age: (b)(6) years.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2019-00512 |
| MDR Report Key | 8379883 |
| Date Received | 2019-02-28 |
| Date of Report | 2019-02-28 |
| Date of Event | 2019-02-01 |
| Date Facility Aware | 2019-02-01 |
| Date Mfgr Received | 2019-02-01 |
| Date Added to Maude | 2019-02-28 |
| 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 | PLACKERS STOP GRINDING |
| Generic Name | MOUTHGUARD, OVER-THE-COUNTER |
| Product Code | OBR |
| Date Received | 2019-02-28 |
| Model Number | STOP GRINDING 1CT |
| Lot Number | 31115 |
| 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 | 2019-02-28 |