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

Model Number SC1200

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

Patient Problem Unspecified Infection (1930)

Event Date 06/01/2021

Event Type  Injury  

Event Description

Using soclean cpap sanitizer keeps giving me severe sinus infections requiring medical treatments vs using antibacterial soap to clean the cpap device.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12016561
• MDR Text Key: 257180074
• Report Number: MW5101939
• Device Sequence Number: 1
• Product Code: LRJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/14/2021

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
• Device Model Number: SC1200
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 79