Auralis 636003USRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05056341675259), received between Nov 19, 2024 and Nov 19, 2024 — classified as 4 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER CLAIMED AN INCREASE IN PRESSURE INJURIES FOR NUMEROUS OF PATIENTS DURING USAGE OF THE AURALIS SYSTEMS WITH SKIN IQ. ON 22 OCT 2024, ARJO BECAME AWARE OF THE INFORMATION THAT TWO PATIENTS SUSTAINED SERIOUS PRESSURE SORE DURING USAGE THE AURALIS SYSTEM. ONE OF TWO PATIENTS (ASSESSED IN THE COMPLAINT WITH OUR INTERNAL REFERENCE NUMBER TW (B)(4) SUSTAINED 2 PRESSURE INJURIES (LEFT ISCHIUM AND LEFT LATERAL THIGH BOTH DEEP TISSUE INJURIES OR DTI'S) AND SECOND PATIENT SUSTAINED 3 PRESSURE INJURIES (ASSESSED IN OUR INTERNAL REFERENCE NUMBER TW (B)(4)-UPPER OCCIPITAL NON-STAGEABLE, LOWER OCCIPITAL DTI, LEFT ISCHIAL STAGE IV) THE FACILITY WAS CONTACTED TO ADRESS THE ISSUE. ADDITIONAL TRAINING WAS PROVIDED ON HOW TO ADJUST THE PUMP SETTINGS FOR THE PATIENT'S COMFORT. THE SYSTEM WAS SWAPPED. NO SYSTEM MALFUNCTION WAS FOUND.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 20722974 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER CLAIMED AN INCREASE IN PRESSURE INJURIES FOR NUMEROUS OF PATIENTS DURING USAGE OF THE AURALIS SYSTEMS WITH SKIN IQ. ON (B)(6) 2024, ARJO BECAME AWARE OF THE INFORMATION THAT TWO PATIENTS SUSTAINED SERIOUS PRESSURE SORE DURING USAGE THE AURALIS SYSTEM. ONE OF TWO PATIENTS (ASSESSED IN THE COMPLAINT WITH OUR INTERNAL REFERENCE NUMBER (B)(4) SUSTAINED 2 PRESSURE INJURIES (LEFT ISCHIUM AND LEFT LATERAL THIGH BOTH DEEP TISSUE INJURIES OR DTI'S) AND SECOND PATIENT SUSTAINED 3 PRESSURE INJURIES (WITH OUR INTERNAL REFERENCE NUMBER (B)(4) UPPER OCCIPITAL NON-STAGEABLE, LOWER OCCIPITAL DTI, LEFT ISCHIAL STAGE IV) THE FACILITY WAS CONTACTED TO ADRESS THE ISSUE. ADDITIONAL TRAINING WAS PROVIDED ON HOW TO ADJUST THE PUMP SETTINGS FOR THE PATIENT'S COMFORT. THE SYSTEM WAS SWAPPED. NO SYSTEM MALFUNCTION WAS FOUND.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 20722962 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER CLAIMED AN INCREASE IN PRESSURE INJURIES FOR NUMEROUS OF PATIENTS DURING USAGE OF THE AURALIS SYSTEMS WITH SKIN IQ. ON 22 OCT 2024, ARJO BECAME AWARE OF THE INFORMATION THAT TWO PATIENTS SUSTAINED SERIOUS PRESSURE SORE DURING USAGE THE AURALIS SYSTEM. ONE OF TWO PATIENTS (ASSESSED IN THE COMPLAINT WITH OUR INTERNAL REFERENCE NUMBER TW (B)(4) SUSTAINED 2 PRESSURE INJURIES (LEFT ISCHIUM AND LEFT LATERAL THIGH BOTH DEEP TISSUE INJURIES OR DTI'S) AND SECOND PATIENT SUSTAINED 3 PRESSURE INJURIES (WITH OUR INTERNAL REFERENCE NUMBER TW (B)(4)- UPPER OCCIPITAL NON-STAGEABLE, LOWER OCCIPITAL DTI, LEFT ISCHIAL STAGE IV) THE FACILITY WAS CONTACTED TO ADRESS THE ISSUE. ADDITIONAL TRAINING WAS PROVIDED ON HOW TO ADJUST THE PUMP SETTINGS FOR THE PATIENT'S COMFORT. THE SYSTEM WAS SWAPPED. NO SYSTEM MALFUNCTION WAS FOUND.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 20722949 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER CLAIMED AN INCREASE IN PRESSURE INJURIES FOR NUMEROUS OF PATIENTS DURING USAGE OF THE AURALIS SYSTEMS WITH SKIN IQ. ON 22 OCT 2024, ARJO BECAME AWARE OF THE INFORMATION THAT TWO PATIENTS SUSTAINED SERIOUS PRESSURE SORE DURING USAGE THE AURALIS SYSTEM. ONE OF TWO PATIENTS (ASSESSED IN THE COMPLAINT WITH OUR INTERNAL REFERENCE NUMBER (B)(4)) SUSTAINED 2 PRESSURE INJURIES (LEFT ISCHIUM AND LEFT LATERAL THIGH BOTH DEEP TISSUE INJURIES OR DTI'S) AND SECOND PATIENT SUSTAINED 3 PRESSURE INJURIES (WITH OUR INTERNAL REFERENCE NUMBER (B)(4) UPPER OCCIPITAL NON-STAGEABLE, LOWER OCCIPITAL DTI, LEFT ISCHIAL STAGE IV) THE FACILITY WAS CONTACTED TO ADRESS THE ISSUE. ADDITIONAL TRAINING WAS PROVIDED ON HOW TO ADJUST THE PUMP SETTINGS FOR THE PATIENT'S COMFORT. THE SYSTEM WAS SWAPPED. NO SYSTEM MALFUNCTION WAS FOUND.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 20722896 ↗