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

Device Problems Device Emits Odor (1425); Patient-Device Incompatibility (2682)

Patient Problems Asthma (1726); Dyspnea (1816); Vomiting (2144)

Event Date 09/18/2021

Event Type  Injury  

Event Description

My husband uses soclean to clean his cpap.There were times that i would have asthma attack or difficulty to breath whenever he would face me with his cpap in use - the air from his cpap would hit me on my face.And the smell from his cpap after cleaning with soclean would throw me up.Fda safety report id # (b)(4).

• Brand Name: SO CLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12532444
• MDR Text Key: 273591471
• Report Number: MW5104196
• Device Sequence Number: 1
• Product Code: LRJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• 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