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

Model Number SC1200

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

Patient Problem Cough (4457)

Event Type  Injury  

Event Description

Soclean2 cpap cleaning device caused bad cough.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 13862791
• MDR Text Key: 287886359
• Report Number: MW5108446
• Device Sequence Number: 1
• Product Code: LRJ
• UDI-Device Identifier: 00187293000860
• UDI-Public: 187293000860
• 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: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SC1200
• Device Lot Number: 2020-06-12
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CPAP
• Patient Outcome(s): Disability
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White