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

Device Problems Nonstandard Device (1420); Device Emits Odor (1425)

Patient Problem Headache (1880)

Event Date 06/30/2021

Event Type  Injury  

Event Description

I was using the "soclean" device to clean my cpap until i noticed an unpleasant odor and taste in my dreamstation cpap wisp nasal cushion and tubing.I stopped using the soclean and returned to soap and water to clean my cpap, which has now been recalled by "philips respironics".My doctors office sent me an email alerting me of the recall.I registered my cpap machine on the website today-(b)(6) 2021.I am wondering if the "soclean" will also issue a recall? i experienced headaches and sinus issues on and off while using the "soclean".It may be why our cpap machines start deteriorating.I have "obstructive sleep apnea" diagnosed in 2012.I have reached out to my doctor for advice on continuing to use my cpap during the philips respironics recall.I am very concerned that permanent lung damage or cancer can occur due to this problem.I hope they replace our cpap quickly to avoid problems continuing or people discontinuing use of their cpap and having obstructive sleep apnea take their lives.(b)(6).Fda safety report id# (b)(4).

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12121555
• MDR Text Key: 260473512
• Report Number: MW5102299
• Device Sequence Number: 2
• 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: 06/30/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• 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): Other; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 70