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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Asthma (1726); Bronchitis (1752)

Event Date 02/10/2021

Event Type  Injury  

Event Description

My husband has a cpap and has used a soclean machine for a few years now.I have had chronic reactive airway disease, asthma, and chronic bronchitis during use.Dates aren't exact because the machine has been used daily for years.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12814339
• MDR Text Key: 280872411
• Report Number: MW5105310
• 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: 11/10/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White