MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-24 for EQUATE BR HDS EF II VIP BR HDS EF II VIP 5PK manufactured by Ranir Llc.
[184457337]
Consumer stated that the bristles from the equate easyflex total power replacement toothbrush heads, 5 count are falling off while using the tooth brush. This is her first time using this product and the 2nd brush from the pack with the same issue. One brush head was returned from package.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2020-00709 |
| MDR Report Key | 9746819 |
| Report Source | CONSUMER |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-01-23 |
| Date Facility Aware | 2020-01-27 |
| Date Mfgr Received | 2020-01-27 |
| Date Added to Maude | 2020-02-24 |
| 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 BR HDS EF II VIP |
| Generic Name | TOOTHBRUSH, POWERED |
| Product Code | JEQ |
| Date Received | 2020-02-24 |
| Returned To Mfg | 2020-02-06 |
| Model Number | BR HDS EF II VIP 5PK |
| 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 | 2020-02-24 |