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

Model Number SC1200

Device Problem Device Emits Odor (1425)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2020

Event Type  Injury  

Event Description

Ozone in water chamber stays; ozone stays in the water chamber after sterilization.When used, it smells excessively.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN FOR CPAP
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 10004717
• MDR Text Key: 189447276
• Report Number: MW5094278
• 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: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 34