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

Device Problems Contamination (1120); Device Emits Odor (1425); Output Problem (3005)

Patient Problems Bronchitis (1752); Hyperglycemia (1905); Unspecified Infection (1930); Cough (4457)

Event Type  Injury  

Event Description

Pt states that about 5 years ago, in (b)(6) 2016, she was placed on a cpap machine.Pt reports that her husband bought a soclean device to clean the cpap.Pt notes immediately after plugging it in, it emits a horrendous odor.Pt states that she followed all the directions and used the device faithfully everyday and notes that the emitted from the machine permeated through the whole room.She notes that despite use of scent plug ins and opening the door to air the room, the smell lingers.Pt states that the odor has changed the smell of the room and the whole house.Pt reports concern that the odor emitted is not a normal occurrence.Additionally, pt reports developing worsening sinuses and lung complications as a result of prolonged use.Pt states constant sinus infections , bronchitis, a horrible cough, now notes a permanent horrible smell in her nose that she states she can't get rid of.Pt also reports having increased asthma attacks, lung issues and the constant use of antibiotics and allergy medications to combat illnesses.Of note, pt stated that after opening up the cpacp machine to clean it and change water reservoir, she noted black mold and had to manually clean device.Pt notes concern that the soclean device was to meant to prevent manual cleaning of the cpap.Pt notes that she spoke with her doctors about the use of the cpap and soclean device and was informed that she is doing everything correctly.Pt reports concern that despite correct usage she is having progressively worsening health complications.Pt states that she is currently concerned with her worsening sinus and lung issues as well as the seemingly permanent odor left in her nose.Pt states that her health issues have gotten severe and prevent her function normally.Pt states that as a diabetic these health complications increase her sugar levels.Pt reports at present she has been 1 week without her cpap machine.Pt alleges speaking with the supplier who told her not to use the cpap machine and wait for a replacement device due to the black mold.

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12032826
• MDR Text Key: 257897030
• Report Number: MW5101991
• Device Sequence Number: 1
• 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: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention