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

Model Number DS6HFLG AND SO CLEAN 2

Device Problems Material Erosion (1214); Material Fragmentation (1261); Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problems Aspiration/Inhalation (1725); Bacterial Infection (1735); Headache (1880); Dizziness (2194); Unspecified Respiratory Problem (4464); Renal Impairment (4499); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

Since i have been using a so clean machine for daily cleaning of my cpap machine (years), i have been suffering with frequent sinus infections.From (b)(6) of 2020 until present i have been living with constant migraine type head aches and dizziness with discharge of foul tasting fluid from my sinuses, when bending over or looking down for a short duration.My cpap machine has been recalled because of insulating foam that also filters incoming air has been deteriorating and being breathed in by users.The deterioration has been caused by the use of my so clean cleaning machine used daily.Since the recall is taking forever and they are telling us to buy a new machine if ours is manufactured before a last years date, i thought this was a ploy to force people to buy new machines.After researching this recall i discovered that this was a real health threat.I went on (b)(6) to inquire about taking this sound insulation/air filter out of my machine.When i disassembled the unit to remove the effected piece of foam, to my horror i only found 10 percent of it left.So i breathed in 90 percent of this toxic foam.I also pieces of foam throughout the unit.I do regular cleanings of all parts of the cpap machine with soap and water.My health has been horrible since (b)(6) of this year.A week long hospital stay for a kidney problem and several weekly visits with doctors with my constant migraine and dizziness.They have done several ct scans and an mri of my head in (b)(6), two spinal taps that revealed unhealthy results.My neurologist and surgeons are still trying to figure out what is causing my symptoms.I will now introduce them to this possible contributor to my condition.Fda safety report id # (b)(4).

• Brand Name: SO CLEAN CPAP MACHINE CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SO CLEAN, INC.
• MDR Report Key: 12916873
• MDR Text Key: 281690676
• Report Number: MW5105725
• 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: 11/29/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: DS6HFLG AND SO CLEAN 2
• Patient Sequence Number: 1
• Patient Outcome(s): Disability