FDA Adverse Event
Malfunction
Summary report: N
BELMONT-BEL-20N
MDR report key: 15040103
·
Received July 18, 2022
Report
- Report Number
- 15040103
- Event Type
- Malfunction
- Date Received
- July 18, 2022
- Date of Event
- June 27, 2022
- Report Date
- July 12, 2022
- Manufacturer
- TAKARA BELMONT CORPORATION, OSAKA FACTORY
- Product Code
- NRU
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT WAS IN THE DENTISTRY CLINIC AND FELL OUT OF THE DENTAL CHAIR. THIS CHAIR DOES NOT HAVE A LOCKING MECHANISM ON THE ARMREST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2911014 | BELMONT-BEL-20N | CHAIR, DENTAL, WITHOUT OPERATIVE UNIT | NRU | TAKARA BELMONT CORPORATION, OSAKA FACTORY | BEL-20N |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2920 DA | Female | Other |