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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Sore Throat (2396)

Event Date 02/02/2020

Event Type  Injury  

Event Description

I have a rested bipap machine air curve 10 in which i used for many years.Then i got a so clean machine to use to clean it.I started having adverse effects, burning throat , headaches.I got to where i couldn't tolerate the machine so i quit using it.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 13315208
• MDR Text Key: 284308133
• Report Number: MW5106855
• Device Sequence Number: 2
• Product Code: LRJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/18/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: METROPOLOL; XARELTO
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White