MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-16 for PLACKERS INTERDENTAL BRUSHES 4 CT manufactured by Ranir Llc.
[179935644]
Consumer stated all four brushes lasted only 4 times. The tips broke off and there was very little bristle. She said she used the brushes before and they were of much better quality. Product was not returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2020-00689 |
| MDR Report Key | 9595679 |
| Report Source | CONSUMER |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-12-19 |
| Date Facility Aware | 2019-12-19 |
| Date Mfgr Received | 2019-12-19 |
| Date Added to Maude | 2020-01-16 |
| 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 | PLACKERS INTERDENTAL BRUSHES 4 CT |
| Generic Name | TOOTHBRUSH, MANUAL |
| Product Code | EFW |
| Date Received | 2020-01-16 |
| Model Number | INTERDENTAL BRUSHES 4 CT |
| Lot Number | 04-021 |
| 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 | 2020-01-16 |