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

Device Problem Product Quality Problem (1506)

Patient Problems Headache (1880); Dizziness (2194)

Event Type  Injury  

Event Description

Headache and dizzy daily; two months ago i purchased a soclean 2 machine to clean my cpap machine.I used it for two months, and noticed that i was spinning (dizzy) every time i tilted my head, laid down/back, and had a migraine-like headache.Every single day.I contacted my doctor, we lowered my pressure to see if that was the problem, but the same symptoms continued.I decided to test a theory and discontinued my use of the soclean 2 machine and the dizziness and headaches are gone.I feel that even after following manufacturers guidelines (letting it run before use, cleaning with their gel) the machine made me sick.Fda safety report id# (b)(4).

• Brand Name: SO CLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN INC.
• MDR Report Key: 10142629
• MDR Text Key: 194935893
• Report Number: MW5094929
• 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: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 131