FDA Adverse Event
Malfunction
Summary report: N
RHINAER STYLUS
MDR report key: 22057704
·
Received May 20, 2025
Report
- Report Number
- 3011625895-2025-00007
- Event Type
- Malfunction
- Date Received
- May 20, 2025
- Date of Event
- April 22, 2025
- Report Date
- May 20, 2025
- Manufacturer
- AERIN MEDICAL INC.
- Product Code
- GEI
- UDI-DI
- 08886479300238
- PMA / PMN Number
- K221907
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
RHINAER STYLUS WAS USED IN A PROCEDURE. THE NURSE EXPLAINED THAT THE BACKSIDE OF THE TREATMENT TIP (THE GREY CASING) BROKE OFF DURING THE PROCEDURE TOWARDS THE END OF THE PROCEDURE. THE PHYSICIAN RETRIEVED THE PIECE WITH A STRAIGHT BLAKESLEY. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 886333 | RHINAER STYLUS | RADIOFREQUENCY PROBE | GEI | AERIN MEDICAL INC. | FG1393 | 08886479300238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |