• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SOCLEAN, INC. SOCLEAN 2 DISINFECTANT, MEDICAL DEVICES Back to Search Results
Device Problems Contamination /Decontamination Problem (2895); Device Damaged by Another Device (2915)
Patient Problem Cough (4457)
Event Date 07/10/2021
Event Type  malfunction  
Event Description
Cough and broke cpap; i have been using the soclean 2 automatic cpap cleaner for two years. Around (b)(6) 2021 i developed a persistent cough that i thought was allergies, and my resmed airsense 10 auto set cpap machine quit working shortly after. The motor became loud and the machine would not blow air. I would find bits of black pepper looking specs in my machine when i would wipe it down. I take allegra and use flonase daily but my cough persisted. I began researching and discovered the ozone cleaning method from the soclean unit was causing cpap machines to break down. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSOCLEAN 2
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN, INC.
MDR Report Key12452795
MDR Text Key271075775
Report NumberMW5103829
Device Sequence Number1
Product Code LRJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/09/2021 Patient Sequence Number: 1
-
-