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

Device Problem Particulates (1451)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/09/2022

Event Type  malfunction  

Event Description

Inhaled filter particles; noticed lots green filter particles in the water reservoir of the resmed airsense 10 device.The device has been cleaned with the soclean ozone device for several years.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN FAMILY OF PRODUCTS
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 13757406
• MDR Text Key: 287249987
• Report Number: MW5108109
• Device Sequence Number: 2
• 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: 03/10/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: CPAP DEVICE
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White