SimplyGo SimplyGo, FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00606959028814), received between Sep 5, 2023 and Sep 24, 2026 — classified as 52 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (25 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Thermal Decomposition of Device

  The device was sent to a third-party service center for investigation. During evaluation, the debug technician noticed that the PCA has a burnt resistor. 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 50890105 ↗
• MalfunctionAug 12, 2026Thermal Decomposition of Device

  The SimplyGo device was sent to a third-party service center for investigation. During evaluation, the third-party service center found a Printed Circuit Assembly (PCA) burnt. Due to the alleged malfunction, the device will be forwarded to the manufacturer 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 50225596 ↗
• MalfunctionJul 14, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25819504 ↗
• MalfunctionApr 24, 2026Overheating of Device

  A SIMPLYGO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH INITIAL ALLEGED COMPLAINT OF BURNING SMELL, DEVICE SHUT OFF AND WON'T TURN BACK ON. DURING EVALUATION, THE SERVICE CENTER FOUND THAT PCA IS BURNED AND REQUIRES REPLACEMENT, INLET FILTER MUST BE REPLACED DUE TO PREVENTIVE MAINTENANCE. ADDITIONALLY, THE DEVICE WAS RETURNED REPAIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24987777 ↗
• MalfunctionApr 23, 2026Degraded

  THIS NOTIFICATION WAS OPENED FOR REVIEW FOR INFORMATION RECEIVED THAT THE SIMPLY GO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH AN ALLEGATION OF SMELL OF BURNING. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND THAT THE PCA WAS BURNT, IT HAS TO BE REPLACED AND SIEVES WERE CLOGGED, THEY HAVE TO BE REPLACED. IN ADDITION, INLET FILTER WILL BE REPLACED DUE TO PREVENTIVE MAINTENANCE, THE COMPRESSOR WAS DEFECTIVE, IT HAS TO BE REPLACED, AND CHECK VALVE COVER WAS CRACKED, IT HAS TO BE REPLACED. THE DEVICE HAS BEEN FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION. 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 24973902 ↗
• MalfunctionApr 10, 2026Electrical /Electronic Property Problem; Excessive 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 24844298 ↗
• MalfunctionApr 9, 2026Overheating of Device

  A SIMPLYGO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE WITH ALLEGATION OD OUT OF BOX FAILURE. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, DURING EVALUATION THE DEBUG TECHNICIAN NOTICED THAT THE PCA HAD A THERMAL EVENT. THE DEVICE WAS NOT REPAIRED AT THIRD PARTY SERVICE CENTER. DEVICE SENT TO MANUFACTURER PRODUCT INVESTIGATION LABORATORY FOR FURTHER INVESTIGATION. 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 24832713 ↗
• MalfunctionApr 8, 2026Excessive Heating

  A SIMPLYGO DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICE HAD A BURNT PCA. ADDITIONAL FINDINGS INCLUDED CLOGGED SIEVES AND A DEFECTIVE, NOISY COMPRESSOR THAT REQUIRED REPLACEMENT. THE INLET FILTER WAS ALSO REPLACED DUE TO PREVENTIVE MAINTENANCE. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24824575 ↗
• MalfunctionApr 1, 2026Overheating of Device

  A SIMPLYGO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED PCA BURN MARKS WAS OBSERVED. ADDITIONALLY, SIEVES AND INLET FILTER PREVENTIVE MAINTENANCE, COMPRESSOR DEFECTIVE AND THE PATIENT'S COMPLAINT ABLE TO REPRODUCE, CONTAMINATION WAS OBSERVED AND THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758608 ↗
• MalfunctionMar 24, 2026Excessive Heating

  A SIMPLYGO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH INITIAL ALLEGED COMPLAINT OF DEVICE HAVING LOW O2. DURING EVALUATION, THE SERVICE CENTER FOUND THAT THE PCA IS BURNT. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674151 ↗
• MalfunctionMar 18, 2026Excessive Heating

  A SIMPLYGO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH ALLEGATION OF THE DEVICE DOES NOT START. DURING EVALUATION, THE THIRD-PARTY SERVICE CENTER FOUND THAT SIEVES ARE CLOGGED, CHECK VALVE COVER IS CRACKED, TUBING KIT, COMPRESSOR ARE CONTAMINATED, FLEX CABLE FROM THE FRONT ENCLOSURES DAMAGED AND THE PCA WAS BURNT. 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 24632089 ↗
• MalfunctionMar 6, 2026Overheating of Device

  A SIMPLYGO DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER WITH AN ALLEGATION OF LOW FIO2 ALARM AND BURNT SMELL. THE CUSTOMER'S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICE'S PRINTED CIRCUIT ASSEMBLY IS BURNT, SIEVES CLOGGED, AND THE CHECK VALVE COVER WAS CRACKED. THE POLLEN FILTER WAS REPLACED FOR PREVENTATIVE MAINTENANCE. IN CONCLUSION, THE DEVICE'S PRINTED CIRCUIT ASSEMBLY WILL NEED TO BE REPLACED. THE INVESTIGATION IS ONGOING. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER SERVICE CENTER FOR FURTHER INVESTIGATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537366 ↗
• MalfunctionMar 6, 2026Overheating of Device; Failure to Power Up

  A SIMPLYGO DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER WITH AN ALLEGATION OF NO POWER. THE CUSTOMER'S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICE'S PRINTED CIRCUIT ASSEMBLY IS BURNT AND SIEVES WERE CLOGGED. THE POLLEN FILTER WAS REPLACED FOR PREVENTATIVE MAINTENANCE. IN CONCLUSION, THE DEVICE'S PRINTED CIRCUIT ASSEMBLY WILL NEED TO BE REPLACED. THE INVESTIGATION IS ONGOING. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER SERVICE CENTER FOR FURTHER INVESTIGATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537358 ↗
• MalfunctionMar 5, 2026Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A SIMPLYGO DEVICE THAT THE PCA HAD A THERMAL EVENT WITH BURN MARKS. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE SERVICE TECHNICIAN FOUND THAT THE PCA HAD BURNED MARKS, SIEVES WERE CLOGGED AND MENTIONED INLET FILTER MUST BE REPLACED DUE PREVENTIVE MAINTENANCE. THE UNIT WILL BE RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LAB FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520954 ↗
• MalfunctionFeb 12, 2026Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A SIMPLYGO DEVICE THAT WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH AN ALLEGATION THAT IT WAS NOT DETECTING CHARGERS. THERE WERE NO REPORTS OF SERIOUS OR PERMANENT HARM OR INJURY, AND NO MEDICAL INTERVENTION WAS REQUIRED. DURING EVALUATION AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND THE PCA WAS FOUND TO BE BURNED. ADDITIONALLY, THE EXHAUST MUFFLER GASKET WAS KINKED AND WORN OUT AND REQUIRED REPLACEMENT. THE SIEVE CANISTERS WERE CLOGGED AND WORN DUE TO HIGH PRESSURE AND LOW OXYGEN. THE INLET FILTER REQUIRED REPLACEMENT AS PART OF PREVENTIVE MAINTENANCE. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LABORATORY FOR FURTHER EVALUATION. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR ASSESSMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327135 ↗
• MalfunctionFeb 9, 2026Overheating of Device

  A SIMPLYGO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH A COMPLAINT OF DEVICE WORKING INTERMITTENTLY. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND IDENTIFIED EVIDENCE OF A THERMAL EVENT, AS THE MAIN PCA WAS BURNT. ADDITIONALLY, THE PCA NEEDS TO BE REPLACED. THE THIRD-PARTY SERVICE CENTER WAS UNABLE TO COMPLETE THE INVESTIGATION, AND THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER PRODUCT INVESTIGATION LABORATORY (PIL) AND INVESTIGATED FURTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292285 ↗
• MalfunctionDec 23, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A SIMPLYGO DEVICE INVOLVING A THERMAL PRODUCT MALFUNCTION. THERE WERE NO REPORTS OF PATIENT HARM, INJURY, OR MEDICAL INTERVENTION. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER, WHERE IT WAS FOUND THAT THE UNIT DID NOT START AND THE PCA WAS BURNED. AS PER CUSTOMER REQUEST, THE UNIT WAS REQUIRED TO BE EVALUATED AT RIQL AND SHIPPED UNREPAIRED. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WAS FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882680 ↗
• MalfunctionDec 23, 2025Overheating of Device; Overheating of Device

  A SIMPLYGO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH AN ALLEGATION OF CONCENTRATION FIO² HS. DURING THE EVALUATION AT THE SERVICE CENTER, THE DEVICE WAS INSPECTED AND FOUND SIEVES ARE CLOGGED, PCA IS BURNED. INLET FILTER NEED TO BE REPLACED DUE TO PREVENTIVE MAINTENANCE. ALL PARTS NEED TO BE REPLACED. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR FURTHER INVESTIGATION. A FINAL REPORT WILL BE SENT ONCE THE INVESTIGATION IS CONCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881197 ↗
• MalfunctionDec 18, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A SIMPLYGO DEVICE INVOLVING A THERMAL PRODUCT MALFUNCTION. THERE WAS NO REPORT OF PATIENT HARM OR INJURY, AND THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER, AND THE DEBUG TECHNICIAN NOTICED THAT THE PCA IS BURNT, THE CANISTER IS NOISY, AND THE INLET FILTER REQUIRES PREVENTIVE MAINTENANCE. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WAS FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843227 ↗
• MalfunctionDec 17, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A SIMPLYGO DEVICE INVOLVING A THERMAL PRODUCT MALFUNCTION. THERE WAS NO REPORT OF PATIENT HARM OR INJURY, AND THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER, AND THE SERVICE CENTER FOUND UNIT DOESN'T TURN ON (OPERATING HOURS AND SOFTWARE VERSION COULDN'T BE READ). PCA IS BURNED. SIEVE CANISTERS ARE WORN OUT. INLET FILTER NEEDS TO BE REPLACED DUE TO PREVENTIVE MAINTENANCE. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WAS FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829262 ↗
• MalfunctionDec 16, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A SIMPLYGO DEVICE INVOLVING A THERMAL PRODUCT MALFUNCTION. THERE WAS NO REPORT OF PATIENT HARM OR INJURY, AND THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER, SIEVES ARE CLOGGED. ONCE PLUGGED IN, IT SMELLS BURN BECAUSE THE PCA IS BURNED. INLET FILTER NEED TO BE REPLACED DUE TO PREVENTIVE INTENANCE. ALL PARTS NEED TO BE REPLACED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. 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 23821444 ↗
• MalfunctionDec 16, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A SIMPLYGO DEVICE INVOLVING A THERMAL PRODUCT MALFUNCTION. THERE WAS NO REPORT OF PATIENT HARM OR INJURY, AND THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER. DURING EVALUATION, THE DEBUG TECHNICIAN NOTICED THAT THE PCA WAS BURNED AND THE PIEZO VALVE WAS STUCK. THE PCA MUST BE REPLACED. THE SIEVES WERE CLOGGED, AND THE INLET FILTER MUST BE REPLACED AS PART OF PREVENTIVE MAINTENANCE. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WAS FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819351 ↗
• MalfunctionDec 10, 2025Overheating of Device; Overheating of Device

  THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, THE THIRD-PARTY SERVICE CENTER FOUND PCA IS BURNT. 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 23767459 ↗
• MalfunctionDec 3, 2025Thermal Decomposition of Device; Excessive Heating; Thermal Decomposition of Device; Excessive Heating

  THIS NOTIFICATION WAS OPENED FOR REVIEW FOR INFORMATION RECEIVED THAT THE SIMPLYGO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION WITH AN ALLEGATION OF LOW O2. DURING THE EVALUATION THE DEVICE WAS VISUALLY INSPECTED AND FOUND THE FOLLOWING: BURNT PCA AND BURN MARKS WERE FOUND, LEAKAGE IN SIEVES, INLET FILTER HAD TO BE REPLACED DUE TO PREVENTIVE MAINTENANCE, PCA O2 SENSOR WAS DEFECTIVE, PRESSURE VALVES AND EXHAUST VALVES WERE OLD AND THE TUBING KIT AND MUFFLER WERE CONTAMINATED. THE THIRD-PARTY SERVICER HAS BEEN INSTRUCTED TO RETURN THE DEVICE AND AFFECTED COMPONENT TO THE MANUFACTURER FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709051 ↗
• MalfunctionDec 2, 2025Overheating of Device; Overheating of Device

  THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, THE THIRD-PARTY SERVICE CENTER FOUND PCA IS BURNT. 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 23694083 ↗