MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 2; DISINFECTANT, MEDICAL DEVICES

Model Number SOCLEAN 2

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 04/27/2021

Event Type  Injury  

Event Description

I have developed cough and spontaneous difficulty breathing since i started using soclean 2 to disinfect and sanitize my cpap machine.It became severe i was admitted through the emergency room on (b)(6) 2021.Followed up with pulmonology and my pft conducted (b)(6) 2021 showed significant response with bronchodilator.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12266667
• MDR Text Key: 264949039
• Report Number: MW5102932
• Device Sequence Number: 1
• Product Code: LRJ
• 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: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SOCLEAN 2
• 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): Hospitalization; Disability
• Patient Age: 47 YR
• Patient Weight: 118