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 PWTB INFIN II SO W/2 EF FL PWTB INFIN II SO W/2 EF FL VIP manufactured by Ranir Llc.
[184457205]
Consumer stated that when he used the rechargeable infinity brush and tilted the toward his face, he feels like "battery acid" came out on his lips and cheek. He said got mild burning but is better now. He claims the acid came out from between his brush head and handle. He has been using these brushes for years. He ran and put baking soda on his face as he got a blister on his face. Purchased right before christmas. The brush was on when this happened. Product was returned for review. No signs of contamination on the outside of the handle. The unit was opened and it was noted that the battery was in good condition with no water intrusion; the seal was in new condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2020-00712 |
| MDR Report Key | 9747143 |
| Report Source | CONSUMER |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-01-27 |
| 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 PWTB INFIN II SO W/2 EF FL |
| Generic Name | TOOTHBRUSH, POWERED |
| Product Code | JEQ |
| Date Received | 2020-02-24 |
| Returned To Mfg | 2020-02-10 |
| Model Number | PWTB INFIN II SO W/2 EF FL VIP |
| 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 |