RhinAer® Stylus FG1393Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08886479300238), received between Feb 1, 2023 and May 29, 2026 — classified as 20 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 reports).

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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT 48 HOURS FOLLOWING A RHINAER PROCEDURE WITH BILATERAL EPISTAXIS. PATIENT HAD A BILATERAL SPHENOPALATINE ARTERY LIGATION AND STAYED IN THE HOSPITAL OVERNIGHT.

  Patient problems: Epistaxis

  MAUDE report 25337279 ↗
• MalfunctionApr 23, 2026Detachment of Device or Device Component

  A STYLUS TREATMENT TIP SEPARATED WHILE PERFORMING A PROCEDURE, RESULTING IN A LOOSE COMPONENT IN THE NASAL PASSAGE. THE LOOSE COMPONENT FROM THE STYLUS TIP WAS RETRIEVED AND NO INJURIES OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24972596 ↗
• MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE BACK OF THE RHINAER STYLUS TIP DETACHED FROM THE DEVICE DURING THE PROCEDURE CAUSING THE TIP TO SLIGHTLY SLIDE. THE PHYSICIAN SCOPED AND SUCTIONED THE NASAL AIRWAY. THE DETACHED COMPONENT WAS NOT RECOVERED. THE RHINAER STYLUS WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY OR COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459547 ↗
• MalfunctionSep 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN BENT THE STYLUS SHAFT TOO AGGRESSIVELY TOWARD THE TIP. THE DEVICE WAS THEN INSERTED IN THE NOSE IN THE POSTERIOR NASAL NERVE AREA. WHEN PRESSURE WAS APPLIED TO THE DEVICE, THE TIP BROKE AND A FRAGMENT DETACHED FROM THE STYLUS TIP. THE LOOSE COMPONENT WAS RETRIEVED FROM THE NASAL PASSAGE. NO PATIENT INJURY OR COMPLICATION WAS REPORTED. THE COMPANY REPRESENTATIVE REVIEWED PROPER BENDING PROCEDURE FOR THE DEVICE AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23040028 ↗
• MalfunctionSep 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN BENT THE STYLUS SHAFT TOO CLOSE TO THE TIP AND APPLIED PRESSURE TO TIP. DURING THE PROCEDURE, THE STYLUS TIP BROKE AND A FRAGMENT DETACHED FROM THE STYLUS TIP. THE LOOSE COMPONENT WAS RETRIEVED FROM THE NASAL PASSAGE. NO PATIENT INJURY OR COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23040019 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 DI

  Patient problems: Epistaxis; Perforation

  MAUDE report 22527489 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT UNCOMPLICATED TREATMENT WITH RHINAER STYLUS. 2.5 WEEKS POST-PROCEDURE THE PATIENT PRESENTED TO LOCAL EMERGENCY ROOM WITH BLEEDING INTO THE OROPHARYNX AND OUT THE LEFT NARIS. A SYNCOPAL EPISODE AND CONCERNS OF HEMODYNAMICS WERE NOTED. THE PATIENT WAS PACKED WITH A BALLOON, GIVEN 1 UNIT OF BLOOD AND TRANSFERRED TO ANOTHER HOSPITAL. PATIENT WAS TAKEN TO THE OR. SPHENOPALATINE ARTERY LIGATION WAS PERFORMED TO ACHIEVE HEMOSTASIS. ENDOSCOPIC INSPECTION OF CONTRALATERAL (RIGHT) SIDE SHOWED NO SIGNS OF MUCOSAL INTERRUPTION OR TRAUMA IN THE AREA OF AN ACCESSORY ARTERIAL BRANCH WITH VERY HEALTHY TISSUE SURROUNDING IT AND GOOD VIABLE MUCOSA. PATIENT WAS SEEN 5 DAYS POST-PROCEDURE AND NO FURTHER ISSUES REPORTED.

  Patient problems: Epistaxis

  MAUDE report 22465346 ↗
• MalfunctionJun 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AERIN REPRESENTATIVE REPORTED THAT THE PHYSICIAN BENT THE STYLUS SHAFT TOO CLOSE TO THE TIP AND APPLIED TOO MUCH PRESSURE DURING USE. THE TIP BROKE. THE LOOSE COMPONENT WAS RETRIEVED FROM THE NASAL PASSAGE. NO PATIENT INJURY OR COMPLICATION WERE REPORTED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22343136 ↗
• MalfunctionMay 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057704 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TREATED BILATERALLY WITH RHINAER STYLUS IN THE OFFICE UNDER LOCAL ANESTHESIA. THE PATIENT PRESENTED TO THE OFFICE 5 DAYS POST-PROCEDURE WITH BRISK BLEEDING THAT WAS NOT ABLE TO BE CONTROLLED IN THE OFFICE SETTING. THE PATIENT WAS TAKEN TO THE OR WHERE A BLEED FROM A BRANCH OF THE RIGHT SPA WAS CONTROLLED WITH CAUTERY. THE PATIENT HAD VOMITED A LARGE AMOUNT OF BLOOD AND FOR SAFETY WAS INTUBATED AND KEPT IN THE ICU OVERNIGHT. THE PATIENT REQUIRED TRANSFUSION OF PRBCS (PACKED RED BLOOD CELLS) AND FFP (FRESH FROZEN PLASMA). THE NEXT DAY THE PATIENT WAS STABLE, EXTUBATED AND SENT HOME. THE PATIENT HAD ANOTHER BRISK, BUT NOT AS SEVERE, BLEED 4 DAYS LATER (9 DAYS POST-PROCEDURE) FROM THE LEFT SIDE. THE PATIENT WAS PACKED IN THE ED TO TEMPORARILY CONTROL THE BLEED, THEN TAKEN TO THE OR WHERE THE BLEED, NEAR THE ATTACHMENT OF THE LEFT MIDDLE TURBINATE, WAS CONTROLLED WITH CAUTERY. A SMALL, LESS SIGNIFICANT BLEED ON THE RIGHT, IN A DIFFERENT SPOT THAN PREVIOUSLY TREATED, WAS ALSO CAUTERIZED. THE PATIENT WAS KEPT OVERNIGHT, DID WELL AND THEN WAS SENT HOME. THE PATIENT FOLLOWED UP 14 DAYS POST-PROCEDURE AND WAS DOING WELL.

  Patient problems: Epistaxis

  MAUDE report 22040092 ↗
• MalfunctionMay 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TREATMENT TIP OF THE RHINAER STYLUS SEPARATED DURING TREATMENT OF THE TURBINATE AT THE END OF PROCEDURE. THE HOUSING FOR THE ELECTRODES DETACHED FROM STYLUS. THE COMPONENT FELL ONTO THE "FLOOR OF THE NOSE" RIGHT BY THE ENTRANCE TO THE NOSE / NOSTRIL. THE BROKEN COMPONENT WAS EASILY IDENTIFIABLE BY THE PHYSICIAN AND WAS EASILY REMOVED. THE PROCEDURE COMPLETED AS PLANNED. NO PATIENT INJURY OR ISSUES REPORTED DUE TO THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21957357 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN PERFORMED AN UNEVENTFUL RHINAER PROCEDURE ON THE PATIENT. TOPICAL ANESTHESIA WAS USED. PATIENT HAD A FOLLOW UP ONE WEEK AFTER THE PROCEDURE WITH A MID LEVEL PROVIDER AND HAD NO UNUSUAL CONCERNS AT THAT TIME. SECOND FOLLOW UP WAS WEEK TWO WITH TREATING PHYSICIAN, A FLEXIBLE RHINOLARYNGOSCOPY WITH DEBRIDEMENT WAS DONE. A SMALL AMOUNT OF BLEEDING WAS NOTED WITH CRUST REMOVAL BUT THE BLEEDING WAS SELF-LIMITED. ONE DAY LATER THE PATIENT COMPLAINED OF OOZING. THE PATIENT REPORTED FEELING FAINT, SAT DOWN AND HIT HER HEAD. THE PATIENT PRESENTED TO A NEARBY ED. A CT SCAN WAS PERFORMED (NO REPORT OF SIGNIFICANCE) AND THE PATIENT REQUIRED A PARIETAL LACERATION REPAIR WITH 10 STAPLES. THE PATIENT WAS INSTRUCTED TO FOLLOW UP WITH CARDIOLOGY. AT THIS TIME NOTHING WAS REQUIRED FOR EPISTAXIS AND PATIENT WAS SENT HOME. THE NEXT MORNING THE PATIENT HAD SIGNIFICANT EPISTAXIS AND WENT BACK TO THE SAME ED. BILATERAL ANTERIOR BALLOON PACKS WERE PLACED AND THERE CONTINUED TO BE SOME OOZING. THE TREATING ENT PHYSICIAN SPOKE WITH THE ED DOCTOR AND ACCEPTED TRANSFER TO TREATING PHYSICIAN'S ED. ONCE AT HOSPITAL, TXA WAS GIVEN AND THE BLEEDING STOPPED. AN ECG REVEALED A RIGHT BUNDLE BRANCH BLOCK

  Patient problems: Epistaxis; Perforation

  MAUDE report 21607678 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN PERFORMED AN UNEVENTFUL RHINAER PROCEDURE ON A PATIENT IN HIS OFFICE. HE INJECTED LOCAL WITH A SPINAL NEEDLE AND THERE WAS SOME BLEEDING ON THE LEFT SIDE IN THE POSTERIOR REGION. THE BLEEDING WAS EASILY STOPPED AND THE PROCEDURE CONTINUED. THE PATIENT WENT HOME AND EXPERIENCED SOME MILD BLEEDING THREE DAYS LATER BUT WAS ABLE TO CONTROL IT AT HOME. THE NEXT DAY THE PATIENT CONTINUED TO BLEED AND PRESENTED TO THE PHYSICIAN'S OFFICE AND WAS PACKED. THE FOLLOWING DAY THE PATIENT BLED AGAIN, THROUGH THE PACKING, AND WAS SENT TO THE ED WHERE THE BLEEDING TEMPORARILY STOPPED. THAT EVENING THE PATIENT WAS TAKEN TO THE OR WHERE THE SOURCE OF BLEEDING WAS FOUND IN THE LEFT POSTERIOR LEFT REGION. OF NOTE, THE MUCOSA WAS SIGNIFICANTLY SWOLLEN. PHENYLEPHRINE PLEDGETS WERE APPLIED AND THE BLEED WAS CONTROLLED WITH CAUTERY. TXA WAS GIVEN. THE PATIENT DID WELL AND HAS HAD NO FURTHER BLEEDING TO DATE. AT 2.5 WEEKS POST PROCEDURE, THE PATIENT FOLLOWED UP AND CRUSTING WAS NOTED. THE PATIENT WAS INSTRUCTED TO CONTINUE WITH NASAL IRRIGATIONS. AT 7 WEEKS POST PROCEDURE, THE PATIENT FOLLOWED UP AND SIGNIFICANT CRUSTING AS WELL AS BILATERAL PURULENCE WAS SEEN. A CULTURE WAS TAKEN AND ANTIBIO

  Patient problems: Bacterial Infection; Epistaxis; Fungal Infection

  MAUDE report 21580349 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT RHINAER AND PRESENTED AT THE EMERGENCY ROOM TWO WEEKS LATER WITH NASAL BLEEDING. THE PATIENT RECEIVED PACKING AT THE ER AND WAS THEN TRANSPORTED TO A SURGICAL FACILITY. THE PATIENT UNDERWENT LIGATION OF THE BLEEDING ARTERY ON ONE SIDE, WHICH STOPPED THE BLEEDING. THE PATIENT RECEIVED A TRANSFUSION AT THAT TIME DUE TO HEMOGLOBIN FALLING TO 8. THE PATIENT IS NOW 5-6 WEEKS OUT AND DOING WELL. THE PATIENT WAS NOT ON ANY ANTICOAGULATION THERAPY.

  Patient problems: Epistaxis

  MAUDE report 20554611 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED WITH RHINAER. NO ISSUES DURING THE PROCEDURE. NO BLEEDING. ONE WEEK POST-PROCEDURE PATIENT'S FAMILY MEMBER CALLED ENT OFFICE REPORTING A SIGNIFICANT BLEED. OFFICE INSTRUCTED PATIENT TO REPORT TO ER. ENT WAS AT HOSPITAL AT THE TIME AND TREATED THE PATIENT. PATIENT HAD BLEEDING ON THE LEFT SIDE. PACKING APPLIED TO CONTROL BLEEDING. PATIENT REQUIRED TRANSFUSION OF 2-3 UNITS OF BLOOD. HEMOGLOBIN COUNT RETURNED TO 9. PACKING WAS LEFT IN PLACE FOR 3-4 DAYS AND THE PATIENT WAS DISCHARGED HOME. ANTICOAGULANT THERAPY WAS STOPPED (PLAVIX). FIVE TO SIX DAYS LATER, THE RIGHT SIDE STARTED TO BLEED. THE PATIENT PRESENTED TO THE ER. PACKING WAS PLACED BUT BLEEDING WAS NOT CONTROLLED. ENT TOOK THE PATIENT TO THE OR. BLEEDING WAS AT THE SPA BELOW THE MIDDLE TURBINATE ATTACHMENT. BLEEDING WAS CONTROLLED WITH CAUTERY. A SOFT PACK WAS LEFT IN PLACE FOR A COUPLE DAYS. AT TIME OF REPORT, IT HAS BEEN 2 MONTHS AND THE PATIENT HAS HAD NO FURTHER ISSUES.

  Patient problems: Epistaxis

  MAUDE report 20401920 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TREATED WITH RHINAER (PNN, SEPTAL SWELL BODIES, INFERIOR TURBINATES). PATIENT IS ON PLAVIX, WHICH WAS HALTED FOR 48 HOURS PRIOR TO TREATMENT AND RESUMED SHORTLY FOLLOWING TREATMENT. PATIENT PRESENTED WITH NOSEBLEED 8 DAYS POST-OPERATIVELY AND AT TIME OF REPORT WAS STILL IN THE HOSPITAL. THE TREATING ENT REPORTED THAT THE PATIENT WAS BLEEDING IMMEDIATELY POST-OPERATIVELY ALONG THE SEPTUM, WHICH WAS ADDRESSED WITH SILVER NITRATE. THE PATIENT WAS SEEN BY AN ENT IN THE ER FOR THE DELAYED BLEEDING EVENT WHO PLACED A RHINO ROCKET.

  Patient problems: Epistaxis

  MAUDE report 20356310 ↗
• InjurySep 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIOR TO TREATMENT WITH THE RHINAER STYLUS, BOTH TOPICAL AND INJECTABLE LOCAL ANESTHESIA WERE ADMINISTERED. PATIENT WAS THEN TREATED WITH THE RHINAER STYLUS. PHYSICIAN TREATED 6-9 LOCATIONS ON EACH SIDE IN THE POSTERIOR NASAL NERVE REGIONCO, THEN TREATED A COUPLE ON EACH INFERIOR TURBINATE. THE POSTERIOR EDGE OF THE INFERIOR TURBINATE WAS THE MOST POSTERIOR TREATMENT SITE. NO OTHER PROCEDURES WERE PERFORMED. EIGHTEEN DAYS POST-PROCEDURE THE PATIENT EXPERIENCED A NOSEBLEED AND CALLED THE TREATING PHYSICIAN'S OFFICE. THE PHYSICIAN AT THE OFFICE INSTRUCTED THE PATIENT TO HOLD PRESSURE ON THEIR NOSE TO HELP STOP THE BLEED. THE BLEEDING DID NOT STOP. THE PATIENT WENT TO THE ER, WAS PACKED AND DISCHARGED. THE PATIENT WAS UNCOMFORTABLE BEING DISCHARGED AND WENT TO A DIFFERENT ER AND WAS ADMITTED. THE DURATION OF THE HOSPITALIZATION AT THE SECOND HOSPITAL IS UNKNOWN AT THIS TIME. THE EXACT LOCATION OF THE BLEEDING IS UNKNOWN. THE TREATING ENT WAS NOT PRESENT WHEN THE PATIENT PRESENTED TO THE ER.

  Patient problems: Epistaxis

  MAUDE report 20220082 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TREATED WITH THE RHINAER STYLUS. 30 DAYS POSTPROCEDURE THE PATIENT DEVELOPED SIGNIFICANT BLEED AND WENT TO THE ER. THE BLEEDING WAS UNCONTROLLED FOR 7 HOURS. THE PATIENT WAS HYPOTENSIVE AND WAS GIVEN TRANEXAMIC ACID TO CONTROL BLEEDING.

  Patient problems: Epistaxis

  MAUDE report 20142267 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD HISTORY OF MULTIPLE NASAL AND SINUS PROCEDURES INCLUDING TOTAL SINUS SURGERY BY ANOTHER SURGEON, MEGA-ANTROSTOMIES, AND SCAR PRESENT IN OPERATIVE REGION. PATIENT PRESENTED WITH COUGH AND POSTNASAL DRAINAGE. SCAR WAS SEEN IN OPERATIVE AREA AND CHANGES PRESENT FROM PRIOR SURGERY. RHINAER WAS PERFORMED UNDER MILD SEDATION WITH LOCAL AND TOPICAL ANESTHESIA. THERE WERE A FEW AREAS TREATED ALONG THE COURSE OF THE POSTERIOR NASAL NERVE. NO TREATMENTS WERE OVERLAPPED. THERE WAS NOTHING UNUSUAL ABOUT THE PROCEDURE. POST PROCEDURE PATIENT WAS GIVEN ANTIBIOTIC, CEPHALEXIN, TOPICAL MUPIROCIN, AND INSTRUCTED TO USE SALINE RINSE. TWO WEEK FOLLOW UP, TREATMENT SITE WAS UNREMARKABLE AND COUGH HAD IMPROVED. DAYS FOLLOWING TWO WEEK FOLLOW UP, THE PATIENT BEGAN EPISTAXIS WHILE AT HOME. WENT BY EMS TO EMERGENCY DEPARTMENT. BY THE TIME OF ARRIVAL, BLEEDING CEASED. BLEEDING WAS TREATED WITH RHINO ROCKET EPISTAXIS DEVICE. MINIMAL TIME SPENT AT ED. TWO DAYS LATER, BLEEDING RECURRED BILATERALLY AND THE PATIENT WAS SEEN IN PHYSICIAN OFFICE. BLEEDING WAS POSTERIOR. PATIENT WAS TRANSFERRED TO HOSPITAL WHERE AN EMBOLIZATION WAS DONE TO THE INTERNAL MAXILLARY AND SPHENOPALATINE ARTERIES BILATERALLY.

  Patient problems: Epistaxis

  MAUDE report 20132158 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TREATED WITH THE RHINAER STYLUS. SIX TREATMENTS WERE ADMINISTERED TO THE POSTERIOR NASAL NERVE REGION ON EACH SIDE. NO COMPLICATIONS WERE NOTED AT THE TIME OF TREATMENT. DAY 5 THE PATIENT WAS SEEN IN THE OFFICE AND WAS NOTED TO HAVE MUCOPURULENT DRAINAGE IN THE MIDDLE MEATUS ON ENDOSCOPIC EXAM AND WAS DIAGNOSED WITH MODERATE ACUTE SINUSITIS (UNRELATED TO STUDY DEVICE/PROCEDURE) AND WAS TREATED WITH PREDNISONE AND DOXYCYCLINE AND ENDOSCOPIC DEBRIDEMENT OF CRUSTING. DAY 93 THE PATIENT WAS SEEN IN THE OFFICE AND WAS NOTED TO HAVE MILD YELLOW CRUSTING AT SEPTAL DEVIATION AND MILD, CLEAR RHINORRHEA, NO NAO AND MILD TISSUE EDEMA ON LEFT SIDE. DAY 170 THE PATIENT HAD A TELEPHONE VISIT AND REPORTED NUMBNESS IN THE BACK OF THE NOSE MAKING IT DIFFICULT TO CLEAR MUCUS FROM THE AREA IN THE MORNING WHEN PATIENT WAKES UP. THE ONSET OF THIS EVENT WAS REPORTED TO BE DAY 121. DAY 353 THE PATIENT INDICATED THE NUMBNESS HAD IMPROVED BUT NOT COMPLETELY RESOLVED. DAY 378 THE PATIENT REPORTED STILL FEELING A LITTLE NUMBNESS, NUMBNESS HAS IMPROVED AND NOT BOTHERSOME AT THIS TIME.

  Patient problems: Hyporesponsive to stimuli

  MAUDE report 19969322 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TREATED WITH RHINAER. A FEW DAYS AFTER THE TREATMENT, THE PATIENT RETURNED COMPLAINING OF NOSEBLEED. PHYSICIAN ASSESSED AND SENT THE PATIENT HOME. THE PATIENT WENT TO ER WAS TREATED WITH BALLOON NASAL PACKING AND RELEASED. PATIENT RETURNED TO ER AND WAS ADMITTED FOR MONITORING OVERNIGHT PER PHYSICIAN REQUEST. PATIENT WAS RELEASED NEXT DAY WITH NO BLOOD TRANSFUSION REQUIRED. THERE WAS NO REPORT OF DEVICE MALFUNCTION.

  Patient problems: Epistaxis

  MAUDE report 19571428 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT IS IN LATE 70S (ESTIMATED TO BE 76) WITH A HISTORY OF CHRONIC NASAL OBSTRUCTION AND CHRONIC RHINITIS. THE PATIENT WAS ON ANTICOAGULANT THERAPY. THE PHYSICIAN BELIEVES ANTICOAGULANT THERAPY WAS DISCONTINUED PRIOR TO RHINAER TREATMENT. THE PATIENT RECEIVED TREATMENT TO THE PNN AREA AND THE INFERIOR TURBINATE UNDER LOCAL ANESTHESIA IN THE OFFICE. THERE WERE NO POST TREATMENT ISSUES AT 2 WEEK FOLLOW UP. AT 1 MONTH POST PROCEDURE THE PATIENT WAS ON VACATION AND EXPERIENCED A NASAL BLEEDING EVENT ON THE LEFT SIDE. THE PATIENT WENT TO THE ER AND WAS SEEN BY ENT PHYSICIAN WHO REFERRED THE PATIENT FOR EMBOLIZATION OF THE ARTERY, WHICH STOPPED THE BLEEDING. THE PATIENT WAS REPORTED TO BE DOING WELL. NO DEVICE PERFORMANCE ISSUES WERE REPORTED.

  Patient problems: Epistaxis

  MAUDE report 19534461 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS SEEKING TREATMENT FOR NASAL OBSTRUCTION, CHRONIC RHINITIS, AND CHRONIC SINUSITIS. THE PATIENT WAS NOT ON ANTICOAGULANT OR ANTIPLATELET THERAPY, DOES NOT HAVE A HISTORY OF HYPERTENSION OR ABNORMAL BLEEDING, AND IS A FORMER SMOKER WHO DISCONTINUED 13 YEARS AGO. THE PHYSICIAN PERFORMED A BALLOON SINUPLASTY, INFERIOR TURBINATE REDUCTION, VIVAER, AND RHINAER WITHOUT COMPLICATION. THE PHYSICIAN SAW THE PATIENT IN HIS OFFICE APPROXIMATELY 18 DAYS LATER, AT WHICH TIME ENDOSCOPIC INSPECTION REVEALED NORMAL HEALING WITH NO EVIDENCE OF BLEEDING OR SCABBING IN THE RHINAER TREATMENT AREA. FIVE DAYS LATER, THE PATIENT EXPERIENCED A NOSEBLEED AND PRESENTED AT THE ER. THE PATIENT RECEIVED BILATERAL NASAL PACKING AND WAS DISCHARGED TO HOME. THE NEXT DAY THE PATIENT PRESENTED AT A DIFFERENT ER WITH BLEEDING AND WAS FOUND TO BE HYPOTENSIVE AND TACHYCARDIC WITH A LOW HEMOGLOBIN LEVEL. THE PATIENT WAS TAKEN TO THE OR. ENDOSCOPIC INSPECTION OF THE AREA REVEALED ACTIVE BLEEDING IN THE POSTERIOR MIDDLE MEATUS. THE BLEEDING AREA WAS CAUTERIZED WHICH RESULTED IN CESSATION OF BLEEDING. THE PATIENT WAS GIVEN A 2-UNIT BLOOD TRANSFUSION. THE PATIENT WAS TAKEN THE ICU FOR OBSERVATION AND DISCHARG

  Patient problems: Epistaxis

  MAUDE report 19389212 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECEIVED TREATMENT WITH RHINAER BY AN OUTSIDE OTOLARYNGOLOGIST. HE WAS SEEN AT AN OUTSIDE ED SHORTLY AFTER THE PROCEDURE FOR EPISTAXIS AND TREATED WITH NASAL CAUTERY AND PACKING. THE PATIENT DENIED ANTICOAGULANT USE. HE CONTINUED TO HAVE EPISTAXIS AND A RHINOROCKET WAS PLACED IN HIS SURGEON'S OFFICE. HE PRESENTED TO THE ED SEVERAL DAYS LATER WITH BLEEDING FROM THE RIGHT NARIS. HGB ON PRESENTATION WAS 10.7 G/DL. PACKING WAS REMOVED AND HE HAD NO ACTIVE BLEEDING, HOWEVER THERE WAS EVIDENCE OF RECENT EPISTAXIS. MEROCEL PACKING WAS PLACED, AND HE WAS ADMITTED FOR OBSERVATION. HE WAS DISCHARGED HOME THE FOLLOWING DAY. THREE DAYS LATER HE PRESENTED TO THE ED WITH RIGHT SIDED EPISTAXIS. THE MEROCELE PACKING WAS REMOVED TO REVEAL BRISK BLEEDING. BLEEDING WAS TEMPORIZING WITH NASOPORE PACKING. HGB AT THIS TIME WAS 8.5 G/DL. CTA HEAD/NECK DID NOT SHOW ACTIVE EXTRAVASATION. HE UNDERWENT EMBOLIZATION OF THE RIGHT SPHENOPALATINE AND ANGULAR ARTERIES. DURING THE PROCEDURE, VASCULAR BLUSH WAS NOTED IN BILATERAL SPHENOPALATINE AREAS AND RIGHT ANGULAR ARTERY. HIS HGB WAS 7.3 G/DL ON POD #1 , AND HE DID NOT RECEIVE A BLOOD TRANSFUSION. HE HAD NO FURTHER EPISTAXIS AND WAS DISCHARGED HOME

  Patient problems: Epistaxis

  MAUDE report 18049953 ↗
• 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 17 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 OCCURRED APPROXIMATELY 6 MONTHS AGO, DATE OF EVENT IS ESTIMATED.

  Patient problems: Epistaxis

  MAUDE report 17213808 ↗