MAUDE Adverse Event Report: UNKNOWN SOCLEAN; DISINFECTANT, MEDICAL DEVICES

Patient Problems Asthma (1726); Unspecified Respiratory Problem (4464)

Event Date 08/29/2023

Event Type  Injury  

Event Description

I purchased a soclean device a few years ago.Since then i have been diagnosed with asthma.At 67 years of age, i also experienced chronic acne and additional respiratory problems.Is there a way to contact soclean to request a refund or a claim for my asthma and my other chronic respiratory problems? (b)(6).

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17692587
• MDR Text Key: 322873092
• Report Number: MW5145235
• 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: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White