MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN; DISINFECTANT, MEDICAL DEVICES

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Headache (1880); Memory Loss/Impairment (1958); Unspecified Respiratory Problem (4464); Skin Inflammation/ Irritation (4545)

Event Date 06/28/2021

Event Type  Injury  

Event Description

Philips dreamstation bipap machine and so clean ozone sanitation machine caused headaches, memory loss, fatigue, and nasal irritation and respiratory issues after use.I used machine after cleaning it and was unable to breathe using machine because nose was filled with mucus.I removed mask and day later became worse.I went to urgent care at (b)(6) to find out what was wrong.I received medication and haven't used machine test were run to rule out other illnesses and was determined that i sustained a respiratory infection.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12225782
• MDR Text Key: 263517339
• Report Number: MW5102759
• Device Sequence Number: 2
• Product Code: LRJ
• Combination Product (y/n): Y
• 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: 07/22/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 104