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

Model Number SC1200

Patient Problems Dyspnea (1816); Cough (4457); Wheezing (4463); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/01/2023

Event Type  Injury  

Event Description

Received new soclean2 machine in the spring.Around the beginning of june i started coughing, wheezing and was very short of breath.Mild linear atelectasis at right lung base.Could indicate minimal infiltration.

• Brand Name: SO CLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SO CLEAN, INC.
• MDR Report Key: 18384468
• MDR Text Key: 331345968
• Report Number: MW5149488
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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?: No
• Patient Sequence Number: 1
• Treatment: AIRSUPRA 2 PUFFS AS NEEDED.; AMLODIPINE 10 MG DAILY.; BREO ELLIPTA ONCE A DAY.; BUPROPIONXL 150 MG DAILY.; C-PAP LISINOPRIL HCTZ 20/25 2 TAB. ; FLONASE ONCE A DAY.; GABAPENTIN 400 MG 2 CAPSULES BID.; LEVOTHYROXINE 100 MCG 1 DAILY.; MELOXICAM 7.5 MG TWICE A DAY.; MUCINEX 1 TABLET TWICE A DAY.; MULTI VITAMIN.; PREDNISONE 20 MG DAILY.; PREVAGEN.; PROBIOTIC.; ROSUVASTATIN 20 MG 1 DAILY.; SOLIFENACIN SUCCINATE 10 MG 1 DAILY.; VITAMIN D.
• Patient Outcome(s): Hospitalization; Required Intervention; Other; Disability
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White