MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 2 OZONE-BASED CPAP CLEANER; DISINFECTANT, MEDICAL DEVICES

Model Number SOCLEAN 2

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Malaise (2359); Blister (4537)

Event Date 01/07/2022

Event Type  Injury  

Event Description

Blistered "nos"; use a soclean 2 ozone-based machine with my cpap.Since increasing frequency of use, daily, have felt extreme aching and fatigue over the last 2-3 months.Suspect it is the source of my unexplained constant ill feeling.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN 2 OZONE-BASED CPAP CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 13455113
• MDR Text Key: 285194504
• Report Number: MW5107210
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SOCLEAN 2
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 129 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White