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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Unspecified Respiratory Problem (4464)

Event Type  Injury  

Event Description

Having problems breathing, phlegm accumulates in throat after use of ozone cleaner along with rash around contact area of face.

• Brand Name: SOCLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 16411859
• MDR Text Key: 310007500
• Report Number: MW5115081
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2023
• Patient Sequence Number: 1
• Treatment: DREAM STATION-CPAP, METOPROLOL, REPATHA, LOSARTAN, RANEXA, PRASUGREL, FUROSEMIDE, FINASTERIDE AND ASPIRIN.
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White