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

Model Number SOCLEAN

Patient Problem Drug Resistant Bacterial Infection (4553)

Event Date 09/27/2023

Event Type  Injury  

Event Description

Recurrent and worsening sinus infection.I have been using a soclean device for several years.I have followed my dme cleaning instructions but also used my soclean daily.I've had issues with a sinus infection since (b)(6) 2023 taking antibiotics continuously.Cultures now reveal drug resistant bacteria.I am receiving care the last month from an infectious disease physician.My ent has been treating me before and still.This week id(infectious disease physician) will decide if i need iv antibiotics after i complete a month of 2 oral antibiotics (rifampin & minocycline).After i received/read the email from soclean that alerted to the dangers of their ozone cleaning i stopped using it in (b)(6) 2024.

• Brand Name: SOCLEAN2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 18885029
• MDR Text Key: 337529740
• Report Number: MW5152604
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SOCLEAN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2024
• Patient Sequence Number: 1
• Treatment: ALLEGRA.; BENADRYL.; COUGH MED.; GABAPENTIN.; HIBICLENS SOAP & MOUTHWASH.; JARDIANCE.; METOPROLOL.; MINOCYCLINE .; MUCUPROPIN OINTMENT.; RIFAMPIN.; TYLENOL.; ZOCOR.; ZOLPIDEM.
• Patient Outcome(s): Disability
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White