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

Model Number SC1200

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Unspecified Infection (1930)

Event Type  Injury  

Event Description

After using soclean cpap cleaner i started getting sinus infections very frequently and terrible headaches.Now that the phillips recall came out i've been reading more about the fda and soclean and see where soclean is not fda approved.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12210827
• MDR Text Key: 263251473
• Report Number: MW5102714
• Device Sequence Number: 1
• Product Code: LRJ
• UDI-Device Identifier: 8729300086
• UDI-Public: 8729300086
• 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: 07/19/2021

1 Device was Involved in the Event

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: No Information
• Device Model Number: SC1200
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 91