FDA Adverse Event Injury Summary report: N

RHINAER STYLUS

MDR report key: 22527489 · Received July 16, 2025

Report

Report Number
3011625895-2025-00010
Event Type
Injury
Date Received
July 16, 2025
Date of Event
April 25, 2025
Report Date
July 17, 2025
Manufacturer
AERIN MEDICAL INC.
Product Code
GEI
UDI-DI
08886479300238
PMA / PMN Number
K221907
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
FL, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

THE PATIENT HAD A BILATERAL RHINAER PROCEDURE PERFORMED IN THE OFFICE UNDER LOCAL, TOPICAL ANESTHESIA WITH NO INJECTION. THERE WERE NO OTHER PROCEDURES PERFORMED AND IT WENT SMOOTHLY. PATIENT IS NOT ON ANTICOAGULANT MEDICATION. TEN (10) DAYS POST PROCEDURE THE PATIENT'S FAMILY MEMBER CALLED THE OFFICE AND RELAYED THAT THE PATIENT HAD CONCERNING NASAL BLEEDING FROM THE RIGHT SIDE. AN AMBULANCE WAS CALLED AND THE PATIENT WAS TAKEN TO THE ER. THE TREATING ENT PHYSICIAN DID NOT HAVE PRIVILEGES AT THE HOSPITAL. THE RIGHT SIDE WAS PACKED WITH A RAPID RHINO BUT THE BLEEDING CONTINUED AND THE LEFT SIDE ALSO REQUIRED PACKING WITH A RAPID RHINO. THE PATIENT REQUIRED A BLOOD TRANSFUSION AND WAS ADMITTED OVERNIGHT. THE PATIENT WAS RELEASED THE NEXT MORNING WITH INSTRUCTION TO FOLLOW UP WITH TREATING ENT PHYSICIAN IN 2-3 DAYS, BUT STARTED BLEEDING AGAIN BEFORE THIS APPOINTMENT. THE ENT PHYSICIAN TOOK HIM TO THE OR AND WAS ABLE TO VISUALIZE A BLEEDING BRANCH OF THE SPA ON THE RIGHT SIDE. THE LOCATION OF THE BLEED WAS CAUTERIZED AND A MEROCEL PACK WAS PLACED. THE PATIENT WAS AGAIN ADMITTED OVERNIGHT. THE SMALL PACKING WAS REMOVED THE NEXT MORNING, NO FURTHER BLEEDING WAS NOTED. THE PATIENT WAS DISCHARGED HOME. THE PATIENT FOLLOWED UP ONE WEEK LATER AND SIGNIFICANT CRUSTING WAS NOTED BILATERALLY ON THE ANTERIOR SEPTUM. THE PHYSICIAN PERFORMED SERIAL DEBRIDEMENTS. THE POSTERIOR NASAL CAVITY HEALED WELL BUT THE ANTERIOR SEPTUM NECROSED RESULTING IN AN APPROXIMATELY 1 CM SEPTAL PERFORATION. AT THE LAST FOLLOW UP (4-5 WEEKS FOLLOWING THE EVENT), THE CRUSTING HAD GREATLY IMPROVED AND THE PATIENT DID NOT HAVE SIGNIFICANT PROBLEMS DUE TO THE PERFORATION. THE PHYSICIAN ATTRIBUTED THE NECROSIS AND EVENTUAL SEPTAL PERFORATION TO THE NASAL PACKING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1534986 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. FG1393 08886479300238

Patients

Seq Age Sex Outcome Treatment
1 77 YR Male Hospitalization| O