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

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Headache (1880); Hemorrhage/Bleeding (1888); Respiratory Distress (2045)

Event Date 02/01/2019

Event Type  Injury  

Event Description

Reporter stated that he uses the soclean cpap cleaner and sanitizer machine and each time he used this machine it produced a gunk like type of substance that gives him headache, bloody nose and respiratory problems.He further reported that each time he sterilizes the machine it goes away for a while and the gunk like substance comes back.

• Brand Name: SOCLEAN CPAP SANITIZING MACHINE
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC
• MDR Report Key: 8608478
• MDR Text Key: 145279700
• Report Number: MW5086620
• 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: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• 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): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 163