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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Myocardial Infarction (1969)

Event Date 11/01/2001

Event Type  Injury  

Event Description

I have had this machine since 2014 and bought a soclean machine about 2 years later, i have used a cpap since 2004, i cannot sleep at all without this machine.Starting last november i started waking up all during the night, sinus headache, nose running, lasting all day.It is getting worse daily, i hand clean my cpap at least once a week and use the soclean every day.I put new filters in both machines regularly.I started using a cpap after i had a heart attack in 2004 and had bypass surgery.Since that time i have had several heart attacks, and am now on a lvad this condition from my cpap and or my soclean machine is slowly taking my life, i cannot go without some sort of sleep aide.I still need to use this machine to get any rest.I am (b)(6) and live only on social security, please help.Got the present cpap from the (b)(6) in 2014 and have not had a test since.When i call the (b)(6) they tell me they are waiting on responses from you company.Fda safety report id # (b)(4).

Event Description

I have had this machine since 2014 and bought a soclean machine about 2 years later, i have used a cpap since 2004, i cannot sleep at all without this machine.Starting last november i started waking up all during the night, sinus headache, nose running, lasting all day.It is getting worse daily, i hand clean my cpap at least once a week and use the soclean every day.I put new filters in both machines regularly.I started using a cpap after i had a heart attack in 2004 and had bypass surgery.Since that time i have had several heart attacks, and am now on a lvad this condition from my cpap and or my soclean machine is slowly taking my life, i cannot go without some sort of sleep aide.I still need to use this machine to get any rest.I am (b)(6) and live only on social security, please help.Got the present cpap from the (b)(6) in 2014 and have not had a test since.When i call the (b)(6) they tell me they are waiting on responses from you company.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 13534728
• MDR Text Key: 285640218
• Report Number: MW5107427
• Device Sequence Number: 2
• 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: 02/09/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: DEFIBRILLATOR; OVER 30 MEDS BOSTON SCI. PACEMAKER
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White