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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Respiratory Distress (2045); Malaise (2359)

Event Date 05/08/2020

Event Type  Injury  

Event Description

I don't know if it caused any.I have sleep apnea, purchased a soclean machine and slowly have gotten sick.I had a hard time inhaling deeply, dry cough, very dry mouth, called doctor.I thought i had covid 19, he said you don't have it.I called pulmonologist office to set appointment, told receptionist what was going on."i told i have a soclean machine", she told me she has had some complaints and to (b)(6) it which lead me here.I disconnected last night (b)(6) 2020, feeling better already.No test was done.My cell # (b)(6), i live in (b)(6).Fda safety report id # (b)(4).

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 10046470
• MDR Text Key: 190780158
• Report Number: MW5094446
• 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: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 95