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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Headache (1880); Burning Sensation (2146); Complaint, Ill-Defined (2331)

Event Date 04/01/2020

Event Type  Injury  

Event Description

A patient called to report the adverse effects he experienced after using a cpap cleaning product.After seeing a commercial on tv he started using this product.He said after using it for quite sometime one day he woke up and he could not breath, his nasals were feeling like they were on fire, headache, sore throat, a lot of mucus and was having lung issues.He thought he was having covid-19 and he took the test and it came back negative.He said he found out that this cleaner is not approved by fda for this purpose, they are marketing it illegally.He said he was told the ozone gas is way above that a human should be around.Even though he stopped using it, he is still having issues so he is scheduled to see an ent specialist.

• Brand Name: DISINFECTANT, MEDICAL DEVICES
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 10320020
• MDR Text Key: 200459510
• Report Number: MW5095704
• 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: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 84