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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 04/12/2020

Event Type  Injury  

Event Description

Soclean cpap cleaner caused sinus issues.I have chronic sinus problems and didn't consider this may be a concern.My problem is not serious because i stopped using the device when i realized it was causing a problem.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 9962181
• MDR Text Key: 187772073
• Report Number: MW5094140
• 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: 04/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 88