FDA Adverse Event
Injury
Summary report: N
NEUROMARK SYSTEM
MDR report key: 19269354
·
Received May 8, 2024
Report
- Report Number
- 3016813690-2024-00001
- Event Type
- Injury
- Date Received
- May 8, 2024
- Report Date
- May 8, 2024
- Manufacturer
- NEURENT MEDICAL LTD.
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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
50-YEAR-OLD FEMALE EXPERIENCED BILATERAL EPISTAXIS AFTER POSTERIOR NASAL NERVE (PNN) ABLATION WITH NEUROMARK DEVICE 20 DAYS POST PROCEDURE. REQUIRED SURGICAL INTERVENTION - BILATERAL SPA LIGATION WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 770239 | NEUROMARK SYSTEM | RADIOFREQUENCY PROBE | GEI | NEURENT MEDICAL LTD. | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Female | Required Intervention |