FDA Adverse Event
Malfunction
Summary report: N
ENDOCLOT
MDR report key: 18927477
·
Received March 18, 2024
Report
- Report Number
- 3013155768-2024-00002
- Event Type
- Malfunction
- Date Received
- March 18, 2024
- Manufacturer
- ENDOCLOT PLUS CO., LTD.
- Product Code
- QAU
- PMA / PMN Number
- K190677
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
EPK2303-01 CLOGGED UP AND POWER COULD NOT BE DELIVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2563260 | ENDOCLOT | ENDOCLOT PHS | QAU | ENDOCLOT PLUS CO., LTD. | EPK2303-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |