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

Model Number SC1200

Patient Problems Apnea (1720); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Tachycardia (2095)

Event Date 12/01/2023

Event Type  Injury  

Event Description

Reporter calling, stating she is experiencing adverse health events after using soclean 2 to clean her resmed cpap (continuous positive airway pressure) device.Reporter states she has been using soclean "since 2018" and was recently advised by her doctor to stop using it.Reporter states she "recently" learned of a product recall on soclean and states she is frustrated that she was never notified by the company.Reporter states that in approximately (b)(6) 2023, she began having increased shortness of breath and "my sleep apnea is getting worse".Reporter states she has been seeing her doctor and they are "still trying to figure it all out".Reporter states she has a sleep study scheduled for (b)(6) 2024.Reporter states that since approximately (b)(6) 2023, she is experiencing high blood pressure and increased heart rate while sleeping; reporter states she has awoken in the middle of the night with a blood pressure of 180/101, and sought treatment at the emergency room.Reporter states her blood pressure and heart rate are not elevated during the day, and she states the increases are only occurring when she enters deep sleep.Reporter states she is planning on calling soclean but has not yet done so.Reporter states she has concerns that soclean is the cause of these health problems.

• Brand Name: SOCLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 18640488
• MDR Text Key: 334630522
• Report Number: MW5151017
• 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: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: SC1200
• Patient Sequence Number: 1
• Treatment: RESMED AIRSENSE 10
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female