MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-31 for EQUATE ESBTWN INTRDNTL SO PICK W/TRVL ESBTWN INTRDNTL SO PICK W/TRVL 50CT manufactured by Ranir Llc.
[184455183]
Consumer stated eq flsbr esbtn 50ct broke the crown of the tooth inside which is the down front teeth. Contacted consumer and he said this was his first time using the product. This event happened with the first brush he used. He sees the dentist every 2-months as he has a good dental plan. Requested we pay for his dental bills to have the crown repaired. Product not returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2020-00699 |
| MDR Report Key | 9654884 |
| Report Source | CONSUMER |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-06 |
| Date Facility Aware | 2020-01-07 |
| Date Mfgr Received | 2020-01-07 |
| Date Added to Maude | 2020-01-31 |
| 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 | EQUATE ESBTWN INTRDNTL SO PICK W/TRVL |
| Generic Name | TOOTHBRUSH, MANUAL |
| Product Code | EFW |
| Date Received | 2020-01-31 |
| Model Number | ESBTWN INTRDNTL SO PICK W/TRVL 50CT |
| Lot Number | 9099B |
| 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 | 2020-01-31 |