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

Patient Problems Dyspnea (1816); Cough (4457)

Event Type  Injury  

Event Description

Reporter stated that her husband is using the soclean product to clean his cpap machine.He was having cough, shortness of breath as a result.The reporter said, he did not know the cleaning device causes that until recently they found out from some source.She also said the device emits some sort of odor.

• Brand Name: DISINFECTANT, MEDICAL DEVICES
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 18475265
• MDR Text Key: 332635971
• Report Number: MW5149951
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic