FDA Adverse Event
Malfunction
Summary report: N
XSTAR
MDR report key: 14605766
·
Received June 6, 2022
Report
- Report Number
- 1211998-2022-00031
- Event Type
- Malfunction
- Date Received
- June 6, 2022
- Date of Event
- January 19, 2022
- Report Date
- April 6, 2023
- Manufacturer
- BEAVER-VISITEC INTERNATIONAL, INC.
- Product Code
- HNN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
(B)(4). (2 OF 8)
Additional Manufacturer Narrative · 0
THE UDI NUMBER AND THE FOLLOWING SECTIONS WERE UPDATED : TYPE OF INVESTIGATION. INVESTIGATION FINDINGS. INVESTIGATION CONCLUSION. 2 OF 8.
Description of Event or Problem · 0
A CUSTOMER ALLEGED THAT THE SAFETY SHIELD ON THE OPTIMUM 30 DEG STRAIGHT W/SAFETY (10/SP) WAS IDENTIFIED AS RETRACTED PRIOR TO USE. THERE WAS NO PATIENT OR USER INVOLVEMENT AND NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153521 | XSTAR | OPTIMUM 30 DEG STRAIGHT W/SAFETY (10/SP) | HNN | BEAVER-VISITEC INTERNATIONAL, INC. | 6045431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |