RhinAer Stylus FG815Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08886479300184), received between Feb 1, 2021 and Jun 27, 2023 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECEIVED ONE TREATMENT ON BOTH SIDES WITH RHINAER STYLUS IN THE POSTERIOR NASAL NERVE REGION, ALONG WITH MAXILLARY BALLOON SINUPLASTY AND TURBINATE OUTFRACTURE. NO DEVICE MALFUNCTION REPORTED. THE PATIENT WAS TREATED IN THE CLINIC UNDER TOPICAL AND LOCAL ANESTHESIA. THE PATIENT WAS SEEN FOR PLANNED FOLLOW-UP VISITS. SOME MINOR BLEEDING REPORTED, THEN APPROXIMATELY 9 DAYS POST-PROCEDURE PRESENTED TO THE ER WITH A BLEED ON ONE SIDE AND WAS PACKED. WHEN PACKING WAS REMOVED, A SERIOUS SPA BLEED DEVELOPED. PATIENT REQUIRED SPA LIGATION TO CONTROL BLEEDING, WAS HELD OVERNIGHT FOR OBSERVATION AND REQUIRED A BLOOD TRANSFUSION. EVENT OCCURED APPROXIMATELY 2 YEARS AGO, DATE OF EVENT IS ESTIMATED.

  Patient problems: Epistaxis

  MAUDE report 17213804 ↗
• MalfunctionOct 6, 2022Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  PRIOR TO USE OF THE RHINAER STYLUS, A PIECE OF THE TREATMENT TIP OF THE STYLUS WAS FOUND TO BE LOOSE. THE NURSE SNAPPED THE PIECE INTO PLACE AND TESTED THE DEVICE. THE PIECE DID NOT APPEAR TO BE LOOSE AND REMAINED INTACT. DURING THE PROCEDURE ON THE RIGHT SIDE, A PIECE OF THE TREATMENT TIP CAME OFF IN THE PATIENT'S NASOPHARYNX. THE PATIENT'S AIRWAY WAS EVALUATED WITH A FLEXIBLE ENDOSCOPE DOWN TO THE CARINA. NO FOREIGN BODIES WERE NOTED. THE PATIENT WAS ALERTED TO AND AWARE OF WHAT HAPPENED. TWO WEEKS POST-PROCEDURE, THE PATIENT WAS REPORTED AS DOING GREAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15548967 ↗
• InjuryOct 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 DURING AN ON-SITE VISIT, A PHYSICIAN REPORTED TREATING A PATIENT THAT PRESENTED IN THE ER ON (B)(6) 2022 WITH A SEVERE NOSEBLEED. THE PATIENT HAD BEEN TREATED WITH THE RHINAER STYLUS TWO WEEKS PRIOR BY ANOTHER PHYSICIAN. THE PATIENT REQUIRED SUCTION AND BOVIE ON THE LEFT SIDE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND RELEASED ON (B)(6) 2022. THE PATIENT RECEIVED A COUPLE UNITS OF BLOOD AND PLATELETS. THE PATIENT WAS CURRENTLY TAKING CLAVIX (BLOOD THINNER).

  Patient problems: Epistaxis

  MAUDE report 15526106 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED ON JUNE 4, 2022 REGARDING A BLEEDING EVENT 2 WEEKS POST-PROCEDURE FOLLOWING TREATMENT IN THE PNN AREA WITH A RHINAER STYLUS. IT WAS REPORTED THAT THE BLEEDING HAD RESOLVED AND HEALED WITH NO FURTHER INCIDENT AS OF (B)(6) 2022. THE TREATING ENT PHYSICIAN ATTRIBUTED THE CAUSE OF THE BLEEDING TO THE PATIENT'S LACK OF COMPLIANCE TO IRRIGATION PROTOCOL AND OTHER CO-MORBIDITIES (I.E., HEAVY SMOKER). THE BLEEDING EVENT WAS INITIALLY DETERMINED TO BE NOT REPORTABLE. ADDITIONAL INFORMATION REGARDING THE EVENT WAS REQUESTED AND PENDING. ON JULY 26, 2022, COMPANY REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION INDICATING THE PATIENT REQUIRED MEDICAL/SURGICAL INTERVENTION TO STOP THE BLEEDING. IN CONSIDERING THE NEW INFORMATION, THE EVENT WAS DETERMINED TO BE REPORTABLE. THE PATIENT (APPROXIMATELY 60 YEARS OLD) WAS TREATED WITH RHINAER STYLUS ON LEFT SIDE IN (B)(6) 2022 (EXACT DATE NOT KNOWN). TWO WEEKS POST-PROCEDURE, THE PATIENT PRESENTED AT THE ER AND WAS TRANSFERRED TO OR FOR SPA LIGATION. THE PATIENT WAS HELD OVERNIGHT FOR OBSERVATION. BLEEDING HAS RESOLVED AND HEALED WITH NO FURTHER INCIDENT. DATE OF BLEEDING EVENT HAS BEEN SUBMITTED AS (B)(6) 2022 SINCE EXACT DAT

  Patient problems: Cardiac Arrest; Epistaxis; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15299352 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED ON JUNE 4, 2022 REGARDING A BLEEDING EVENT 2 WEEKS POST-PROCEDURE FOLLOWING TREATMENT IN THE PNN AREA WITH A RHINAER STYLUS. THE TREATMENT WITH RHINAER STYLUS WAS COMPLETED IN THE OR IN CONJUNCTION WITH A CO-PHYSICIAN RHINOPLASTY. IT WAS REPORTED THAT BLEEDING HAS RESOLVED AND HEALED WITH NO FURTHER INCIDENT AS OF (B)(6) 2022. THE TREATING ENT PHYSICIAN ATTRIBUTED THE CAUSE OF THE BLEEDING TO A HARD SCAB DISLODGING DUE TO LACK OF PATIENT COMPLIANCE OF IRRIGATION PROTOCOL. THE SURGEON THAT COMPLETED THE RHINOPLASTY INSTRUCTED THE PATIENT NOT TO IRRIGATE PER THEIR NORMAL RHINOPLASTY PROCEDURE PROTOCOL. THE BLEEDING EVENT WAS INITIALLY DETERMINED TO BE NOT REPORTABLE. ADDITIONAL INFORMATION REGARDING THE EVENT WAS REQUESTED AND PENDING. ON JULY 26, 2022, COMPANY REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION INDICATING THAT THE PATIENT REQUIRED MEDICAL/SURGICAL INTERVENTION TO STOP THE BLEEDING. THIS NEW INFORMATION REGARDING SURGICAL INVENTION REQUIRED THE EVENT TO BE REPORTED. THE PATIENT (APPROXIMATELY 40 YEARS OLD) WAS TREATED WITH THE RHINAER STYLUS ON THE RIGHT SIDE IN (B)(6) 2022 (EXACT DATE NOT KNOWN). TWO WEEKS POST-PROCEDURE, THE PATIENT PRESENTED AT

  Patient problems: Epistaxis

  MAUDE report 15299351 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT WAS TREATED WITH THE RHINAER STYLUS. PATIENT DOES NOT HAVE A HISTORY OF NOSE BLEEDS BUT BLED DURING THE ANESTHESIA INJECTION. PATIENT WAS TREATED IN 3 LOCATIONS IN THE BASAL LAMELLA AREA AND 3 LOCATIONS ALONG THE INFERIOR TURBINATE ON BOTH SIDES. TWO WEEKS POST-TREATMENT ON 7/24/2022, THE PATIENT WAS ADMITTED TO THE ER WITH EPISTAXIS OF BOTH NOSTRILS. PATIENT REQUIRED BILATERAL EMBOLIZATION TO STOP BLEEDING AND RECEIVED A BLOOD TRANSFUSION (3 UNITS). BLEEDING OCCURRED IN THE BASAL LAMELLA AREA. PATIENT WAS ADMITTED TO THE HOSPITAL AND RELEASED HOME ON (B)(6) 2022.

  Patient problems: Epistaxis

  MAUDE report 15290140 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RHINAER STYLUS WAS USED TO TREAT THE POSTERIOR NASAL NERVE REGION OF THE NASAL AIRWAY. BOTH RIGHT AND LEFT SIDE WERE TREATED. FIVE DAYS POST-PROCEDURE, THE PATIENT WENT TO THE ER DUE TO BLEEDING. BLEEDING WAS ON THE LEFT SIDE OF NOSE, POSTERIOR ASPECT. BLEEDING WAS CONTROLLED WITH A LATEX BALLOON. THE PHYSICIAN SAW THE PATIENT THE DAY AFTER THE BLEEDING EVENT AND THE NEXT DAY. PATIENT IS DOING WELL. THERE WAS NO REPORT OF DEVICE MALFUNCTION BY THE CLINIC. PHYSICIAN REPORTED ON 07/13/2021 THAT SHE HAD SEEN THE PATIENT AGAIN AND THAT THE PATIENT IS DOING WELL.

  Patient problems: Epistaxis

  MAUDE report 12170971 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RHINAER STYLUS WAS USED TO THE TREAT THE POSTERIOR NASAL NERVE REGION OF THE NASAL AIRWAY. THE PROCEDURE WAS PERFORMED BILATERALLY AND RELATIVELY UNREMARKABLY ACCORDING TO THE PHYSICIAN. THE PHYSICIAN REPORTED SOME MINOR OOZING AT THE END OF THE CASE THAT WAS CONTROLLED WITH AN EPI SOAKED COTTON PLEDGET. THE PATIENT HAD SOME SELF LIMITED OOZING THAT EVENING AND THE NEXT DAY WHICH STOPPED WITHIN 24 HOURS OF THE PROCEDURE AND DID NOT NEED ANY INTERVENTION. 14 DAYS POST-PROCEDURE, THE PATIENT CAME INTO THE OFFICE WITH SOME CONGESTION. THERE WERE CRUSTS IN BOTH NASAL PASSAGES THAT WERE REMOVED WITHOUT ANY BLEEDING AT THAT TIME. THREE WEEKS POST-PROCEDURE, THE PHYSICIAN RECEIVED A CALL FROM THE ER. THE PATIENT HAD STARTED BLEEDING SPONTANEOUSLY, OVER 100ML IN TOTAL. THE PHYSICIAN WAS UNABLE TO CONTROL THE BLEEDING AT THE BEDSIDE AND TOOK THE PATIENT TO THE OPERATING ROOM FOR RIGHT SPENOPALATINE ARTERY LIGATION. THERE WAS A SMALL ARTERIAL BLEEDER AT THE RIGHT TREATMENT SITE. THE LAST FOLLOW-UP VISIT WITH THE PATIENT OCCURRED ONE MONTH FOLLOWING THE BLEEDING EVENT. THE PATIENT HAS HEALED NOW. THERE WAS NO REPORT OF DEVICE MALFUNCTION BY THE CLINIC.

  Patient problems: Epistaxis

  MAUDE report 11619776 ↗
• InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  33 DAYS POST PROCEDURE, PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINT OF ONGOING WORSENING NOSEBLEED FOR PAST 2 DAYS. PATIENT STATED THAT THE NOSEBLEED PRESENTED 2 DAYS AGO FOR THE FIRST TIME WHEN PATIENT TRIED TO BLOW NOSE. PATIENT WAS TAKEN TO THE LOCAL ER WHERE PACKING WAS DONE AND PATIENT WAS DISCHARGED HOME. PATIENT HAD A SECOND EPISODE WHEN A FAMILY MEMBER ATTEMPTED TO PUT TAMPONS IN NOSE BUT WHEN BLEEDING WAS NOT CONTROLLED PATIENT WAS BROUGHT INTO THE EMERGENCY DEPARTMENT VIA EMS. ON EMS ARRIVAL PATIENT WAS NOTED TO BE HYPOTENSIVE AND TACHYCARDIC, PATIENT RECEIVED 2 G OF TXA, 2250 CC OF IV FLUID, AND WAS GIVEN 1 UNIT OF BLOOD IN THE EMERGENCY DEPARTMENT ON ARRIVAL AND ANOTHER UNIT AFTERWARDS. ENT PHYSICIAN WAS NOTIFIED. PATIENT UNDERWENT CAUTERIZATION OF RIGHT POSTERIOR NASAL BLEED AND REMOVAL OF BLOOD CLOTS BY ENT PHYSICIAN. HB REMAINED STABLE. PATIENT WAS DISCHARGED SAME DAY OF THE PROCEDURE. CLINIC HAS CONFIRMED THAT PATIENT IS DOING WELL NOW.

  Patient problems: Epistaxis

  MAUDE report 11262689 ↗