NaturaLyte 08-1231-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840861101641), received between Mar 16, 2018 and Mar 16, 2018 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY CLINIC MANAGER REPORTED THAT A PATIENT ALLEGED EXPERIENCING SHORTNESS OF AIR (SOA) DUE TO THEIR 1K BATH WITH NATURALYTE. THE CLINIC MANAGER STATED THAT THE PATIENT REPORTED THIS ISSUE TO HAVE OCCURRED SOMETIME IN JANUARY, HOWEVER, THE EXACT DATE WAS NOT PROVIDED. THE CLINIC MANAGER CONFIRMED THAT THE PATIENT HAS COMPLETED ALL TREATMENTS WITHIN THE TIME PERIOD AT THE CLINIC WITHOUT ANY REPORTED ISSUES. FURTHERMORE, NO OTHER PATIENTS HAVE HAD ANY ISSUES RELATED TO THE USE OF NATURALYTE. THE PATIENT REPORTED TO THE CLINIC MANAGER THAT THEY WENT TO THE HOSPITAL WHERE THEY RECEIVED A CT SCAN WHICH SUBSEQUENTLY OPENED THEIR BLOOD VESSELS AND RELIEVED THEIR SHORTNESS OF AIR. FURTHER HOSPITAL DETAILS WERE REQUESTED, HOWEVER, WERE NOT AVAILABLE AS THEY WERE NOT PROVIDED TO THE FACILITY. THE CLINIC MANAGER REPORTED THAT THE PATIENT HAS A HISTORY OF PARANOIA. THE LOT NUMBER OF THE NATURALYTE WAS UNKNOWN. THE PATIENT HAS SINCE RETURNED TO THE CLINIC AND RECEIVED TREATMENTS WITHOUT FURTHER ISSUE OR REOCCURRENCE OF THE REPORTED ISSUE.

  Patient problems: Dyspnea

  MAUDE report 7344908 ↗