MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 2; DISINFECTANT, MEDICAL DEVICES

Catalog Number SC1200

Device Problem Nonstandard Device (1420)

Patient Problems Arrhythmia (1721); Fever (1858); Unspecified Infection (1930); Pneumonia (2011); Swollen Lymph Nodes/Glands (4432)

Event Date 11/11/2020

Event Type  Injury  

Event Description

I began having cold symptoms in (b)(6) 2020, which elevated to very high fevers (104+), taken to er and admitted, covid was negative, all sorts of tests were run.Immediately put on iv antibiotics and kept in hospital for 5 days, initial diagnosis was pneumonia, with interstitial lung disease, cause unknown.Bronchoscopy performed due to lymph node swelling, with negative results.Everything resolved for a few months but reoccurred in (b)(6) 2021 for 3 days.Once again hospitalized and tests run and given iv antibiotics, once fever reduced, was discharged from hospital, with no diagnosis.Hospitalized again in (b)(6) 2021, for 3 days, same symptoms, same tests.Fever reduced and discharged as fever of unknown origin.Questioned doctors about cpap and soclean machine use and no one had any answers.Visited er with same symptoms in (b)(6) 2021, 11 tests, chest x-ray and ct of abdomen, with same results.Then again on (b)(6) 2022, cold-like symptoms returned, administered 3 covid self-tests, all results negative.Temp spiked to 104.5, contacted emergency after hours medical advice and was instructed to alternate taking tylenol and advil every four hours.I saw a doctor in my clinic on (b)(6) 2022 with a fever of 103 degrees and an elevated heart rate of 109.He ordered several blood tests and a chest x-ray.I had an elevated white cell count - 14.7 (range s/b 1.5 - 7.5) and other elevated labs, chest x-ray was clear.Diagnosis - infection and fever of undetermined origin or cause - the same diagnosis as most of the other instances of illness.I have been using the cpap since 2008.I purchased and started using the soclean machine in (b)(6) 2017.My lungs now have opacities and may be irreparably damaged.I was informed of a possible problem using the soclean machine on (b)(6) 2022 and about the article by the fda, from my sleep apnea doctor while scheduling a new sleep study.I have stopped using the soclean machine, disconnected and removed it from my bedside.Since this same type of illness continues to occur for me, and now knowing that the fda is questioning the use of ozone to clean cpap machines, hoses, nose pieces, i am inclined to think this is the cause of all my illnesses.I have heard of the recall on the cpap and bipap machines, but not on the soclean.In my opinion, soclean is responsible for notifying consumers of this problem.If i would have had this information when originally published, i could have avoided urgent care and 4 hospital visits and all the costs involved.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 15438163
• MDR Text Key: 300182677
• Report Number: MW5112079
• 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: 09/13/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: SC1200
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: BETA-SITOSTEROL PLANT STEROLS; CQ-10; D3; MULTIDOPHILUS; MULTIVITAMIN ; SIMVASTATIN
• Patient Outcome(s): Required Intervention; Disability; Hospitalization; Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White