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

Model Number SC1200

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Eye Injury (1845)

Event Date 04/01/2020

Event Type  malfunction  

Event Description

Purchased the soclean cpap machine cleaner.Having been using as directed for the last 2 weeks and i am now experiencing some shortness of breath and eye issues.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 9952851
• MDR Text Key: 187747161
• Report Number: MW5094101
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SC1200
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1