MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN2 FAMILY OF PRODUCTS; DISINFECTANT, MEDICAL DEVICES

Device Problem Use of Device Problem (1670)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/22/2022

Event Type  Injury  

Event Description

I saw my pulmonary md, in november and we discussed the use of the cpap machine, which i started using again.I have had 4 bronchial (prednisone and antibiotics) treatments since december.When i asked my doctor about the soclean machine he stated that i should have never purchased it.I was not aware that it would be harmful to use with my cpap machine.I've had to use symbicort twice daily and rescue inhaler several times a day.

• Brand Name: SOCLEAN2 FAMILY OF PRODUCTS
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 16631491
• MDR Text Key: 312329099
• Report Number: MW5116054
• 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: 03/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ATENOLOL; CPAP ; MAGNESIUM 400MG; MONTELUKAST; PROAIR; PROBIOTIC; SYMBICORT; ZYRTEC 10MG
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Hispanic
• Patient Race: White