FDA Adverse Event
Injury
Summary report: N
GUM PROXABRUSH GO-BETWEENS WIDE
MDR report key: 15116416
·
Received July 27, 2022
Report
- Report Number
- 0001413787-2022-00215
- Event Type
- Injury
- Date Received
- July 27, 2022
- Date of Event
- February 10, 2020
- Report Date
- February 10, 2020
- Manufacturer
- SUNSTAR AMERICAS INC.
- Product Code
- EFW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS MDR REPORT IS GENERATED RETROSPECTIVELY BASED ON COMPLAINTS AUDIT.
Description of Event or Problem · 0
CONSUMER HAD PURCHASED THE PROXABRUSH GO-BETWEENS AND THE VERY FIRST TIME SHE HAD USED THE BRUSH, IT CAME OFF AND POKED HER IN THE GUM. SHE THEN HAD AN INFECTION. WHEN SHE PUSHED IT IN AND PULLED IT OUT, THE BRUSH WAS OFF THE HANDLE AND ON HER TONGUE. SHE WENT TO THE DOCTOR AND GOT ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2316468 | GUM PROXABRUSH GO-BETWEENS WIDE | TOOTHBRUSH, MANUAL | EFW | SUNSTAR AMERICAS INC. | 3614FC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other |