• 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 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 DISINFECTANT, MEDICAL DEVICES Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Fatigue (1849); Headache (1880); Memory Loss/Impairment (1958); Unspecified Respiratory Problem (4464); Skin Inflammation/ Irritation (4545)
Event Date 06/28/2021
Event Type  Injury  
Event Description
Philips dreamstation bipap machine and so clean ozone sanitation machine caused headaches, memory loss, fatigue, and nasal irritation and respiratory issues after use. I used machine after cleaning it and was unable to breathe using machine because nose was filled with mucus. I removed mask and day later became worse. I went to urgent care at (b)(6) to find out what was wrong. I received medication and haven't used machine test were run to rule out other illnesses and was determined that i sustained a respiratory infection. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSOCLEAN
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN, INC.
MDR Report Key12225782
MDR Text Key263517339
Report NumberMW5102759
Device Sequence Number2
Product Code LRJ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/22/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received07/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
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: 07/23/2021 Patient Sequence Number: 1
-
-