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

Device Problems Device Emits Odor (1425); Patient-Device Incompatibility (2682)

Patient Problem Dyspnea (1816)

Event Date 05/27/2021

Event Type  No Answer Provided  

Event Description

Used a soclean 2 last night.It disinfected at 10:00am on (b)(6) 2021 and i went to bed at 10:00pm and when i put the mask on it had a strong odor.I put the mask on and eventually the smell went away.Used my cpap machine through the night.The next day, i was having trouble breathing and my lungs don't feel right.I used one time and my breathing is terrible.I am needing an inhaler.I am returning the product to apriadirect where i purchased it from.I called them and told them what happened and i need to return it.They just wanted to sell me a different machine.I will clean it myself going forward.

• Brand Name: SOCLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 11912835
• MDR Text Key: 253994533
• Report Number: MW5101640
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/28/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 71