MAUDE Adverse Event Report: SoClean Inc. SOCLEAN2; DISINFECTANT, MEDICAL DEVICES

Device Problem Material Deformation (2976)

Patient Problems Headache (1880); Inflammation (1932)

Event Date 07/01/2020

Event Type  Injury  

Event Description

Soclean 2 ozone melted sound abatement foam in respironics remstar plus c-flex system one ds260hs.Caused head ache, nose inflammation, and nose bleeds.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SoClean Inc.
• MDR Report Key: 12210750
• MDR Text Key: 263223474
• Report Number: MW5102694
• 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: 07/15/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention