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

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problems Cough (4457); Nodule (4551)

Event Date 03/13/2017

Event Type  Injury  

Event Description

Chronic cough started; chest ct showed pulmonary nodules, non malignant.Multiple tests to try to determine cause of chronic cough; no definitive cause found.Multiple treatments without any help with cough.Used philips dreamstation for over ten years; used soclean machine for multiple years.Philips now has a recall on this product r/t reported adverse effects.Serial # (b)(4), humidifier serial # (b)(4).Fda safety report id # (b)(4).

• Brand Name: SO CLEAN MACHINE
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12253691
• MDR Text Key: 264512010
• Report Number: MW5102876
• Device Sequence Number: 3
• 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: 07/28/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 65 YR
• Patient Weight: 113