MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 2 CPAP CLEANER & SANITIZER; DISINFECTANT, MEDICAL DEVICES

Model Number SOCLEAN 2

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Irritation (1941)

Event Date 11/13/2018

Event Type  Injury  

Event Description

Bought a soclean 2 cpap cleaner from (b)(4).Used it for several weeks.After several weeks of use, noticed a burn like irritation where my cpap nasal mask touched my face, particularly around my nose.Stopped using machine and contacted the distributor, (b)(4).Returned item in december 2018 for a refund.(not technically a medical device but a device cleaner).Fda safety report id# (b)(4).

• Brand Name: SOCLEAN 2 CPAP CLEANER & SANITIZER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 10024029
• MDR Text Key: 190002625
• Report Number: MW5094360
• 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: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SOCLEAN 2
• Device Catalogue Number: SC1200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 82