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

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

Patient Problems Atrial Fibrillation (1729); Dyspnea (1816); Low Oxygen Saturation (2477); Cough (4457); Wheezing (4463)

Event Date 10/12/2021

Event Type  Injury  

Event Description

Since (b)(6) 2021 i sometimes have shortness of breath, wheezing and bad coughs.Plus my oxygen levels have been low- 89-92.My drs can not find a reason.Lab tests have been ok.On (b)(6) 2021, i had a-fib and had to go to the hospital.The doctors said it's because my lungs are affecting my heart.I need to know what damages can occur from the dreamstation and using the so clean machine - so my doctors can try to help me.Fda safety report id# (b)(4).

• Brand Name: CLEANING PRODUCT
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12703978
• MDR Text Key: 278823906
• Report Number: MW5104972
• Device Sequence Number: 2
• Product Code: LRJ
• 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: 10/23/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 72 YR
• Patient Weight: 100