FDA Adverse Event
Injury
Summary report: N
EQUATE PWTB OCK FLSS&PICKS
MDR report key: 10096945
·
Received May 28, 2020
Report
- Report Number
- 1825660-2020-00773
- Event Type
- Injury
- Date Received
- May 28, 2020
- Date of Event
- April 30, 2020
- Report Date
- May 28, 2020
- Manufacturer
- RANIR LLC
- Product Code
- JEQ
- UDI-DI
- 68113122403
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CONSUMER ALLEGED SHE BROKE A TOOTH WHILE USING THE DUAL ZONE TOOTHBRUSH. CUSTOMER IS SEEKING COMPENSATION FOR MEDICAL BILL FOR THE REPLACEMENT OF HER TOOTH. WHEN SHE WENT TO CLOSE HER MOUTH, HER TOOTH WAS HANGING. SHE PUSHED IT BACK IN TO PLACE. THIS HAPPENED MID (B)(6) AND SHE KEPT IT IN PLACE FOR A MONTH. DENTIST WAS CLOSED DUE COVID-19, SO SHE PULLED HER OWN TOOTH OUT ON (B)(6). SHE TOOK RUM AND TRIED TO NUMB HER GUM AND SHE PULLED HER OWN TOOTH. SHE HAS HAD A CROWN ON HER TOOTH. SHE STILL HASN'T SEEN A DENTIST BECAUSE THE DENTIST IS CLOSED DUE TO COVID 19.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 562528 | EQUATE PWTB OCK FLSS&PICKS | TOOTHBRUSH, POWERED | JEQ | RANIR LLC | PWTB OCK FLSS&PICKS | 68113122403 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |