FDA Adverse Event
Injury
Summary report: N
NEUROMARK SYSTEM
MDR report key: 20787907
·
Received November 26, 2024
Report
- Report Number
- 3016813690-2024-00002
- Event Type
- Injury
- Date Received
- November 26, 2024
- Date of Event
- October 29, 2024
- Report Date
- November 26, 2024
- Manufacturer
- NEURENT MEDICAL LTD.
- Product Code
- GEI
- PMA / PMN Number
- K222032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLEEDING IS A KNOWN POTENTIAL ADVERSE EVENT AND IS DOCUMENTED IN THE DEVICE LABELLING.
Description of Event or Problem · 0
PATIENT UNDERWENT THE NEUROMARK PROCEDURE ON (B)(6) 2024 AND ON (B)(6) 2024 (28 DAYS POST PROCEDURE) THE SUBJECT EXPERIENCED SEVERE EPISTAXIS FROM THE LEFT NASAL CAVITY. THE EVENT REQUIRED AN ED VISIT AND CAUTERIZATION AND SPA LIGATION TO CONTROL THE EPISTAXIS. THE SAE IS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2452309 | NEUROMARK SYSTEM | RADIOFREQUENCY PROBE | GEI | NEURENT MEDICAL LTD. | FS-004-01 | 105469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male | Required Intervention |