FDA Adverse Event
Malfunction
Summary report: N
ENDOCLOT
MDR report key: 20062570
·
Received August 26, 2024
Report
- Report Number
- 3013155768-2024-00007
- Event Type
- Malfunction
- Date Received
- August 26, 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
ENDOCLOT POWDER WOULD NOT DEPLOY OUT OF CATHETER 3 TIMES. HAD TO SWITCH TO INJECTABLE EPINEPHERIN INSTEAD OF USING ENDOCLOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1159079 | ENDOCLOT | ENDOCLOT PHS | QAU | ENDOCLOT PLUS CO., LTD. | EPK2303-01 | A223051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |