MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN2 CPAP SANITIZING EQUIPMENT; DISINFECTANT, MEDICAL DEVICES

Model Number SC1200

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Chest Pain (1776); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 01/01/2022

Event Type  Injury  

Event Description

I am unaware of an original onset date except to say that i have been using the soclean cpap sanitizing equipment for several years and have noticed irritation to my sinuses and throat mucosa.I have developed a chronic cough and occasionally experienced tightness in my chest.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN2 CPAP SANITIZING EQUIPMENT
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 15699490
• MDR Text Key: 302810535
• Report Number: MW5112977
• 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: 10/27/2022

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 Model Number: SC1200
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2022
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White