FDA Adverse Event
Death
Summary report: N
BRITEPRO
MDR report key: 19236777
·
Received May 3, 2024
Report
- Report Number
- 3006061749-2024-00020
- Event Type
- Death
- Date Received
- May 3, 2024
- Date of Event
- April 3, 2024
- Report Date
- May 3, 2024
- Manufacturer
- FLEXICARE MEDICAL LTD
- Product Code
- CCW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
NOTIFICATION OF PATIENT DEATH RECEIVED AFTER INITIAL REPORT WAS RECEIVED.
Description of Event or Problem · 0
EVENT AS DESCRIBED BY COMPLAINEE - EMERGENCY INTUBATION. MULTIPLE HANDLES DIDN'T WORK (SAME LOT NUMBER). FINALLY PATIENT WAS INTUBATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1278530 | BRITEPRO | LARYNGOSCOPE | CCW | FLEXICARE MEDICAL LTD | 200604126 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death| R |