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

Model Number SOCLEAN2

Device Problem Device Emits Odor (1425)

Patient Problem Malaise (2359)

Event Date 01/01/2021

Event Type  Injury  

Event Description

I purchased and used soclean2 to clean my cpap machine.This left a smell even after 8 hours of waiting as per manufacturer guidelines.I let the cpap run for an hour before breathing in and disconnected the soclean machine.Even after all this the cpap machine was creating a weird smell and i work up from sleep feeling sick.My cpap machine no longer works properly.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN INC
• MDR Report Key: 11139085
• MDR Text Key: 226316290
• Report Number: MW5098727
• Device Sequence Number: 1
• Product Code: LRJ
• 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: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SOCLEAN2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 100