MAUDE Adverse Event Report: SO CLEAN, INC. SO CLEAN (SONIC CLEANER FOR CPAP EQUIPMENT); DISINFECTANT, MEDICAL DEVICES

Model Number SC 1200

Patient Problems Dyspnea (1816); Cough (4457)

Event Date 05/18/2019

Event Type  Injury  

Event Description

I have been on a cpap machine since about 2004 (resmed).About 8 years ago, i purchased a soclean machine to automatically clean my tubing and face mask.After a while i started noticing a smell after first using my equipment after leaving.A smell that was undescribable.I started coughing with congestion and constantly bringing up mucous almost all day.My doctor would check me as there was like a bronchial cough and noises in my chest.I have had x-rays showing nothing wrong with my chest but the coughing and breathing difficulty continued.I was put on symbicort for breathing but coughing, and breathing difficulty continued.Machine model sc1200, serial # (b)(6).I have reached out to so-clean to report this and they said they would send a prepaid label to send it back to them and would refund my cost of machine.I asked if they were recalling the machines and they said no, only the ones that reported.Problems they are listing my complaint as an injury.

• Brand Name: SO CLEAN (SONIC CLEANER FOR CPAP EQUIPMENT)
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SO CLEAN, INC.
• MDR Report Key: 18536048
• MDR Text Key: 333329358
• Report Number: MW5150479
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SC 1200
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: APPLE CIDER VINEGAR; ATOR VASTATIN ; BIOTIN ; CARVEDILOL ; FOLIC ACID ; HYDROCHLOROTHYAZIDE ; LEVOTHYROXINE; OXYBUTRIN ; PROBIOTICS; SYMBICORT INHALER
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Race: White