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U.S. Department of Health and Human Services

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

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SOCLEAN, INC. SOCLEAN 2 DISINFECTANT, MEDICAL DEVICES Back to Search Results
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).
 
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Brand NameSOCLEAN 2
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN, INC.
MDR Report Key13169988
MDR Text Key283329427
Report NumberMW5106471
Device Sequence Number1
Product Code LRJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received01/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 01/04/2022 Patient Sequence Number: 1
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