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

Model Number SC1200

Device Problem Product Quality Problem (1506)

Patient Problems Erythema (1840); Pain (1994); Irritability (2421); Swelling/ Edema (4577)

Event Date 08/10/2021

Event Type  Injury  

Event Description

Facial skin and mucous membrane swelling, redness, irritation and pain after cleaning cpap equipment in the soclean 2 product.Although soclean warrants this product for two (2) years from the date of purchase, the company does not respond to customer service calls from customers and/or email complaints delivered to their company email address.This health problem required consultation and treatment by a dermatologist and sleep apnea staff at a university medical center.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12554162
• MDR Text Key: 274255440
• Report Number: MW5104291
• Device Sequence Number: 1
• Product Code: LRJ
• UDI-Device Identifier: 00187293000860
• UDI-Public: 187293000860
• 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: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SC1200
• Device Lot Number: SO2273759
• 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): Required Intervention; Disability
• Patient Age: 70 YR