MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN2; DISINFECTANT, MEDICAL DEVICES

Model Number SC1200

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cough (4457); Unspecified Respiratory Problem (4464)

Event Type  Injury  

Event Description

Started using soclean device with my philips respironics cpap and shortly after started a chronic cough and nasal problems.Been diagnosed with bronchiectasis.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 15322013
• MDR Text Key: 298984161
• Report Number: MW5111786
• 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: 08/26/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SC1200
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: LOSARTAN; PANAPORASIL ; POTASSIUM; PREMARIN; SPIRONOLACTONE; SYNTHROID; VITAMIN D
• Patient Outcome(s): Disability
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White