MAUDE Adverse Event Report: SLEEP8 INC. SLEEP8 OZONE SANITIZING DISINFECTANT; DISINFECTANT, MEDICAL DEVICES

Patient Problems Dyspnea (1816); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 01/01/2021

Event Type  Injury  

Event Description

Reporter calling because she is having problems with chronic cough, shortness of breath, "lung irritation", and chest pain ever since she began using "sleep8 ozone disinfectant" in combination with her resmed device.Reporter states her symptoms began on approximately (b)(6) 2021, and that she has been going to the doctor "chronically" for the past couple of years due to her symptoms.She states she has been on steroid medications, cough medications, has had chest x-rays, and been evaluated by a cardiologist due to her ongoing health problems.Reporter states she fears she has suffered permanent damage and that she is scheduled for another "wellness check" at her doctor's office "next week".Reporter states sleep8 is the only cleaner she has ever used with her resmed.Reporter also states she discovered other reports about sleep8 with cpap (continuous positive airway pressure) device use on "maude" from 2019, and that this alarmed and upset her.Reporter states she is upset that "sleep8 knew about problems as far back as 2019" yet continued to sell their product for use.Reporter states she has called "fda allegations" but was only able to leave a message and has not received a call back.Reporter also states she will be contacting sleep8 with the intention of talking to someone in "their legal department".Reference report: mw5147160.

• Brand Name: SLEEP8 OZONE SANITIZING DISINFECTANT
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SLEEP8 INC.; 1569 mallory lane; brentwood TN 37027
• MDR Report Key: 17975224
• MDR Text Key: 326349633
• Report Number: MW5147159
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Patient Sequence Number: 1
• Treatment: "COUGH MEDICATIONS"; "STEROID MEDICATIONS"; RESMED AIRCURVE 10 VAUTO
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female