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

Device Problem Insufficient Information (3190)

Patient Problem Bronchitis (1752)

Event Date 06/01/2021

Event Type  Injury  

Event Description

Been having on and off issues with acute bronchitis that may be associated with use of cpap soclean unit.Been having the issue on and off since purchasing the machine and most recently having it and no antibiotics or other meds have helped.In looking for possible reasons, i began to wonder about the soclean equipment.Continuing bronchial irritation.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN CAPAP CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12050295
• MDR Text Key: 258176079
• Report Number: MW5102048
• Device Sequence Number: 1
• 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: 06/18/2021

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 129