EverFlo EverFlo w/Oxygen Percentage Indicator, 230V, IKKRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00606959032569), received between Dec 28, 2016 and Sep 23, 2026 — classified as 3 deaths, 5 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (6 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Thermal Decomposition of Device

  This notification was opened for review due to an allegation of the concentrator shows a burn mark on the housing. There was no allegation of patient harm/injury.The manufacturer's investigation is ongoing. A supplemental follow-up report will be submitted when the manufacturer's investigation is complete.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869640 ↗
• InjuryAug 18, 2026Defective Alarm; Failure to Deliver

  The manufacturer received information alleging that a patient using an EverFlo oxygen concentrator experienced insufficient oxygen delivery during clinical and therapeutic use. The patient's daughter reported that the patient's peripheral oxygen saturation (SpO2) decreased to 70% for an unspecified period of time, with no device alarm sounding during the alleged event. The patient's condition reportedly deteriorated, resulting in EMS transport to a hospital and subsequent admission.The device underwent an initial inspection by a technical service team, including testing of the pressure delivery system and alarm conditions related to flow and FiO2. The device passed the preliminary testing, and the alarms functioned as intended during simulated low-flow and decreased FiO2 conditions. It was noted that the device had been in use for approximately 5,100 hours over the past 7 months (equivalent to 24 hours per day) and had accumulated a corresponding amount of dust.The manufacturer's investigation is ongoing. A follow-up report will be submitted when the manufacturer's investigation is complete.

  Patient problems: Low Oxygen Saturation

  MAUDE report 50309251 ↗
• MalfunctionAug 12, 2026Thermal Decomposition of Device

  The manufacturer was contacted in reference to the Everflo device. There was a report of device interior full of white powder. There was no allegation of serious or permanent harm or injury. No medical intervention was specified by the patient. The device was returned to the Third-party service center for evaluation. During the evaluation of the device there was evidence of Front cabinet has external burned, Label warning need to be replaced, Rear Cabinet need to be replaced because is smell a tobacco, Sieve is leakage zeolite, Tube Braided Silicone needs to be replaced, Manifold and OPI Concentrator tubing are out of use is yellowed and fissure and is losing air and contaminated with tobacco, Flowmeter is broken, Inlet Filter need to be replaced for preventive maintenance. The device was requested to be sent to the manufacturer's Product Investigation Lab (PIL) for further investigation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50220977 ↗
• MalfunctionJul 29, 2026Thermal Decomposition of Device

  A EVERFLO device was returned to a third-party service center with allegation of circuit board defective. During the initial evaluation of the device at the third-party service center, the service technician observed PCA was burnt. The device was forwarded to manufacturer product investigation laboratory (PIL) for further investigation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50071506 ↗
• MalfunctionApr 15, 2026Excessive Heating

  THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, THE THIRD-PARTY SERVICE CENTER FOUND A BURNT PCA. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION. A FINAL REPORT WILL BE SENT ONCE THE INVESTIGATION IS CONCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24883350 ↗
• MalfunctionApr 14, 2026Electrical Shorting

  THIS NOTIFICATION WAS OPENED FOR REVIEW FOR INFORMATION RECEIVED THAT A CUSTOMER USING AN EVERFLO DEVICE STATING, "THE CONCENTRATOR CAUSED A SHORT CIRCUIT." THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877533 ↗
• InjuryMar 30, 2026Insufficient Flow or Under Infusion

  DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE THAT THE O2 LEVEL IS TOO LOW BECAUSE THE SIEVES ARE LEAKING ZEOLITE AND THE FLOWMETER WAS CRACKED. NO PARTS WILL BE REPLACED. THE DEVICE WAS SCRAPPED PER COSTUMER REQUEST.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24737422 ↗
• MalfunctionMar 17, 2026Failure to Deliver

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT DURING ROUTINE MAINTENANCE PERFORMED BY THE CUSTOMER ON AN EVERFLO DEVICE, IT WAS DISCOVERED THAT AN EQUIPMENT'S FLOW METER INDICATED A CORRECT FLOW RATE (5 L/MIN), BUT NO ACTUAL FLOW WAS REACHING THE PATIENT OUTLET. THE EQUIPMENT DID NOT TRIGGER AN ALARM. FURTHER INVESTIGATION BY THE CUSTOMER REVEALED THAT THE INTERNAL PATIENT FILTER HAD SPLIT, CAUSING A FLOW LEAK INSIDE THE DEVICE. THE DEFECTIVE FILTER LACKED A LOT OR BATCH NUMBER, AS IT HAD BEEN REPLACED DURING EARLIER SERVICE. UPON CHECKING STORAGE, IT WAS FOUND THAT THERE WERE OTHER FILTERS FOUND TO BE DEFECTIVE OR PARTIALLY COMING APART. THIS POSES A RISK BECAUSE PATIENTS MAY UNKNOWINGLY RECEIVE INADEQUATE FLOW. THE ISSUE MAY HAVE PERSISTED FOR A LONG TIME, AS THE AFFECTED FILTER HAD BEEN IN USE FOR 1.5 YEARS. NO PATIENT HARM OR INJURY WAS REPORTED AS THE DEVICE WAS NOT IN PATIENT USE AT THE TIME. DESPITE THREE GOOD FAITH-EFFORT ATTEMPTS ON 10/14/2025, 01/22/2026, AND 02/18/2026 TO (B)(6), THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE COMPLETED. IF ANY ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24620735 ↗
• MalfunctionMar 12, 2026Overheating of Device

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A EVERFLO DEVICE. THERE WAS ALLEGATION OF PROBLEMS WITH CABLE, BANG AND DEVICE STARTED TO SMOLDER. NO FAULT DETECTED HOWEVER, OXYGEN LEVEL WAS AT THE LIMIT. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24580957 ↗
• MalfunctionDec 5, 2025Melted; Melted

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF A EVERFLO DEVICE'S INTAKE FILTER BEING MELTED IN CONNECTION TO COMPRESSOR AND LOOSE STRIP FOUND AT COMPRESSOR WHICH MAY HAVE COME LOOSE FROM THE COMPRESSOR AND GOT IN THE WAY OF THE FAN DURING USE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23730286 ↗
• MalfunctionNov 23, 2025Circuit Failure; Circuit Failure

  THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, THE THIRD-PARTY SERVICE CENTER FOUND BURNED COMPONENTS (CAPACITOR, COMPRESSOR, POWER CORD, FRONT AND REAR CABINET). DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION. A FINAL REPORT WILL BE SENT ONCE THE INVESTIGATION IS CONCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23627559 ↗
• MalfunctionSep 16, 2025Overheating of Device; No Apparent Adverse Event; Overheating of Device; No Apparent Adverse Event

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE COMPRESSOR WAS NOT WORKING AND THERE WAS HOUSING DAMAGE WITH A BURN MARK ON THE FRONT/TOP ON AN EVERFLO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065877 ↗
• MalfunctionSep 12, 2025Overheating of Device; Failure to Deliver; Overheating of Device; Failure to Deliver

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING NO OXYGE ON A EVERFLO DEVICE. THERE WAS NO REPORTED HARM. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION, IT WAS NOTED THAT THE DEVICE HAD A BURNED PCA AND THE DEVICE DOES NOT POWER ON. THE ROOT CAUSE IS CONFIRMED TO BE THERMAL DAMAGE OF THE PCA. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE MANUFACTURER OBSERVED A DUST-LIKE CONTAMINATION ON THE REAR ENCLOSURE, SCRATCHES ON THE FRONT ENCLOSURE, BROWN DISCOLORATION ON THE COMPRESSOR INLET TUBE (INDICATIVE OF TOBACCO USE). KINKED/PINCHED CANNULA TUBE. THERMAL DAMAGE ON THE PCA (F3, T3) AND BLOWN FUSE (F1) WHICH IS INDICATIVE OF A VOLTAGE SPIKE THAT OCCURRED EXTERNAL TO THE DEVICE. PIL WAS UNABLE TO POWER ON AND TEST THE DEVICE DUE TO THERMAL DAMAGE ON THE PCA. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23036716 ↗
• InjuryJul 16, 2025Noise, Audible; Noise, Audible

  THE MANUFACTURER RECEIVED INFORMATION REGARDING AN EVERFLO OXYGEN CONCENTRATOR DEVICE. THERE IS AN ALLEGATION FROM A USER THAT THEY SUFFERED A STROKE IN THE HOSPITAL DUE TO THE DEVICE BEING TOO LOUD. NO MEDICAL INTERVENTION WAS SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Stroke/CVA

  MAUDE report 22527182 ↗
• MalfunctionJul 8, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION RELATED TO AN EVERFLO DEVICE. THE ALLEGATION IS A DEFECTIVE CIRCUIT BOARD. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING EVALUATION, THE SERVICE TECHNICIAN REPORTS PCA SHORT CIRCUIT, SIEVES ARE CLOGGED, INLET FILTER NEEDS TO BE REPLACED DUE TO PREVENTIVE MAINTENANCE. THE PCA IS ALSO BURNED. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER PRODUCT INVESTIGATION LABORATORY AND INVESTIGATED FURTHER. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22454687 ↗
• MalfunctionJun 5, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING FUSE ON THE CIRCUIT BOARD DEFECTIVE RELATED TO THE DEVICE EVERFLO INTL OXYGEN CONCENTRATOR. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND CLOGGED SIEVES, CONTAMINATED SILICONE BRAIDED TUBE, INLET FILTER THAT NEED TO BE CHANGED DUE TO PREVENTIVE MAINTENANCE, CONTAMINATED MANIFOLD, DEFECTIVE PCA (FUSE BROKEN), DAMAGED OVERLAY KIT WERE FOUND. THE CUSTOMER COMPLAINT WAS REPRODUCED. LASTLY THE DEVICE PASSED ALL TEST RESULTS. THE DEVICE PCA WAS FORWARDED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FROM THIRD PARTY SERVICE CENTER TO FURTHER INVESTIGATE AN ALLEGATION OF "BLOWING FUSES/THERMAL EVENT". THE INVESTIGATION CONFIRMED THAT THE PCA APPEARED TO HAVE RECEIVED A MAINS VAC VOLTAGE SPIKE/EOS/ESD EVENT OR AN INCORRECT MAINS VOLTAGE CONNECTION DURING SERVICING. THE INCOMING MAINS MOV CONDUCTORS HAVE EXPERIENCED A PHYSICAL DEPARTURE AND SUBSEQUENT THERMAL CREEP EVENT FROM AN OVER VOLTAGE CONDITION. COMPONENTS VEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22149073 ↗
• MalfunctionMay 17, 2025Device Emits Odor; No Apparent Adverse Event; Device Emits Odor; No Apparent Adverse Event

  A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. CUSTOMER COMPLAINT ALARM AND SMELLS CHARRED WAS CONFIRMED. DURING THE EVALUATION OF THE DEVICE, THEY FOUND CANISTER ASSY, O2 PILOT SOLENOID WORN, FLOWMETER CRACKED, MANIFOLD ASSY, OVERLAY KIT AND BRAIDED SILICONE TUBE DAMAGED. THE DEVICE WAS REPAIRED. REPORTABLE SINCE DEVICE ISSUE/EVENT HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041045 ↗
• MalfunctionMay 8, 2025Fire; Fire

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A EVERFLO DEVICE. THE CUSTOMER SMOKED WHILE USING THE DEVICE. THIS LED TO AN IGNITION THAT SPREAD VIA THE OXYGEN GOGGLES TO THE FIRE AND DAMAGED COMPONENTS. THE USER ADMITTED IT WAS HER FAULT. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986831 ↗
• MalfunctionMay 5, 2025Temperature Problem; Temperature Problem

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO AN EVERFLO INTL DEVICE. THERE WAS AN ALLEGATION OF A SMOKING CONCENTRATOR, A BURST HOST, THE DEVICE DISPLAYING "A RED ERROR" AND SMOKE COMING OUT OF THE O2 OUTLET WHENEVER THE CONCENTRATOR WAS TURNED ON. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. DURING EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER, IT WAS FOUND THAT THE UNIT WAS EMITTING SMOKE, AND THE SCREEN WAS DISPLAYING ERRORS. ALL ERRORS WERE BECAUSE THE CANISTER WAS LEAKAGE ZEOLITE. THERE WAS NO CRACKED HOSE, MANIFOLD AND COMPRESSOR REPAIR KIT WERE FOUND TO BE BROKEN. NO OTHER DEVICE PROBLEMS WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962404 ↗
• MalfunctionDec 29, 2024Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A EVERFLO INTL OPI. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THERE WERE SOME SECONDARY FINDINGS LIKE PCA BURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032228 ↗
• MalfunctionDec 12, 2024Overheating of Device; Overheating of Device

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF EVERFLO INTL OPI THAT THE PATIENT ALLEGES THAT THE DEVICE HAS A BURNT POWER CORD. THE POWER CORD CONNECTOR NEEDS TO BE REPLACED. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913723 ↗
• MalfunctionAug 21, 2024Fire; Smoking; Fire; Smoking

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE WAS SMOKING AND A FIRE WITH POLICE INTERVENTION. THE PATIENT EXPERIENCED MILD SMOKE INHALATION. THE DEVICE HAS BEEN RETRIEVED FROM THE PATIENT. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Aspiration/Inhalation

  MAUDE report 20015344 ↗
• MalfunctionJun 8, 2024Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES IN THE AIR PATH. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19493288 ↗
• MalfunctionJun 7, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF EVERFLO INTL OPI THAT THE PATIENT ALLEGES THAT THE DEVICE HAS A DEFECTIVE POWER CORD. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19485634 ↗
• MalfunctionMay 3, 2024Powder Leak; Powder Leak

  THE MANUFACTURER RECEIVED INFORMATION REGARDING AN EVERFLO DEVICE. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. DURING EVALUATION OF THE DEVICE, IT WAS DISCOVERED THE DEVICE HAD DEFECTIVE MOLECULAR SIEVES. THE DEVICE SIEVE LEAKED AND THE INTERIOR OF THE DEVICE WAS FULL OF WHITE POWER. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19244129 ↗