FDA Adverse Event
Malfunction
Summary report: N
BRITEPRO SOLO STUBBY
MDR report key: 19943244
·
Received August 8, 2024
Report
- Report Number
- 3006061749-2024-00030
- Event Type
- Malfunction
- Date Received
- August 8, 2024
- Date of Event
- July 9, 2024
- Report Date
- July 9, 2024
- Manufacturer
- FLEXICARE MEDICAL LTD
- Product Code
- CCW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
UDI INFORMATION IS NOT AVAVILBE AT THE TIME OF THIS SUBMISSION.
Description of Event or Problem · 0
DETAILS OF THE EVENT AS TOLD TO MANUFACTURER 'DURING INTUBATION THE CAP AT THE END DISCONNECTED AND THE USER LOST THEIR VIEW BECAUSE THE LIGHT WENT OUT'
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1065947 | BRITEPRO SOLO STUBBY | LARYNGOSCOPE | CCW | FLEXICARE MEDICAL LTD | 231201803 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |