FDA Adverse Event
Injury
Summary report: N
CLARIFIX II SYSTEM, US
MDR report key: 11728036
·
Received April 26, 2021
Report
- Report Number
- 3006345872-2021-00003
- Event Type
- Injury
- Date Received
- April 26, 2021
- Date of Event
- March 1, 2021
- Report Date
- April 26, 2021
- Manufacturer
- ARRINEX, INC.
- Product Code
- GEH
- UDI-DI
- 00868438000234
- PMA / PMN Number
- K190356
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
A PATIENT HAD A CLARIFIX PROCEDURE AND CONCOMITANT POLYP REMOVAL ON (B)(6) 2021. FOUR WEEKS POST OP, ON (B)(6) 2021, THE PATIENT PRESENTED WITH SOME BLEEDING THAT LATER MOVED TO SEVERE. THE PATIENT WAS PACK WITH GAUZE AND BALLOON UNSUCCESSFULLY. THE BLEEDING WAS UNILATERAL ON THE RIGHT SIDE. EMBOLIZATION WAS LATER TRIED AT A HOSPITAL UNSUCCESSFULLY. ON (B)(6) 2021 THE PATIENT HAD A SUCCESSFUL LIGATION PROCEDURE. NO FURTHER BLEEDING HAS BEEN NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 620108 | CLARIFIX II SYSTEM, US | CRYOSURGICAL UNIT AND ACCESSORIES | GEH | ARRINEX, INC. | CFX-1000 | UNKNOWN | 00868438000234 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other |