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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Asthma (1726); Dry Eye(s) (1814); Dyspnea (1816); Headache (1880); Nasal Obstruction (2466); Taste Disorder (4422); Wheezing (4463); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

I have developed several deeply concerning symptoms including but not limited to: loss of taste and sense of smell, chronic productive cough with yellow to green sputum, chronic nasal congestion, shortness of breath, intermittent soft wheezing or whistling sound with breath, dry eyes, intermittent, brief sinus headaches, mostly in morning, significant and seemingly permanent change in voice tone and quality.Increased asthma.The above listed symptoms have either developed and/or significantly worsened within the past few years.My recent (past 6 months) loss of taste and smell prompted internet research early this morning, wherein i discovered that my use of the 'soclean 2' cpap equipment sanitizing machine is likely causing all of my worsening symptoms.As of this morning, the soclean 2 machine is disconnected and will not be used again.I am scheduling an appointment with my pulmonologist and perhaps an ent for evaluation and treatment.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 13169988
• MDR Text Key: 283329427
• Report Number: MW5106471
• 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: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Race: White