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

Device Problem Device Emits Odor (1425)

Patient Problem No Code Available (3191)

Event Date 12/06/2019

Event Type  Injury  

Event Description

Pt called to report possible adverse reaction to soclean machine used to clean cpap.Pt stated that his wife uses a cpap machine and he shares a room with her.He said they recently started using the soclean machine to clean the cpap, and since starting use of the soclean machine, his allergies have worsened and is coughing up mucus.Pt stated the smell from the soclean machine is very strong.Pt contacted the mfr and was given some troubleshooting instructions but wanted to report to fda as well.

• Brand Name: SOCLEAN MACHINE
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 9445994
• MDR Text Key: 170297710
• Report Number: MW5091557
• 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: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR