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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Respiratory Distress (2045)

Event Date 04/06/2020

Event Type  Injury  

Event Description

I have been coughing pretty bad since purchasing and using soclean cpap cleaner.I believe it was purchased in (b)(6) of this year 2020.Also having to use my inhaler more frequently and developed bronchitis so bad that i was coughing up blood.I have a photo of one of the times this happened that i took so that my primary doctor, dr (b)(6) with (b)(6) could view on 4/06/2020, the same day of the morning it happened, i was prescribed antibiotics and cough syrup.I have discontinued use of the soclean as of today (b)(6) 2020 after speaking with my pulmonary doctor.Fda safety report id# (b)(4).

• Brand Name: SO CLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SO CLEAN INC.
• MDR Report Key: 9995147
• MDR Text Key: 189152976
• Report Number: MW5094255
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR