MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-21 for CARE ONE MNTB ORB FL SO MNTB ORB FL SO 2PK manufactured by Ranir Llc.
[184457182]
Consumer stated she used the tooth brush for a week. She felt bristles in her mouth and realized that the brush was falling apart. She said, "i literally made myself throw up because this product was going into my side. " she believes she also swallowed some of the bristles. Consumer was refunded for the product and the toothbrush was returned for review.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2020-00708 |
| MDR Report Key | 9742164 |
| Report Source | CONSUMER |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-25 |
| Date Facility Aware | 2020-01-25 |
| Date Mfgr Received | 2020-01-25 |
| Date Added to Maude | 2020-02-21 |
| 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 | CARE ONE MNTB ORB FL SO |
| Generic Name | TOOTHBRUSH, MANUAL |
| Product Code | EFW |
| Date Received | 2020-02-21 |
| Returned To Mfg | 2020-02-11 |
| Model Number | MNTB ORB FL SO 2PK |
| Lot Number | 109 |
| 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 | 2020-02-21 |