MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 2; SLEEP EQUIPMENT MAINTENANCE SYSTEM

Model Number SC1200

Device Problem Insufficient Information (3190)

Patient Problems Rash (2033); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 04/13/2020

Event Type  Injury  

Manufacturer Narrative

File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.In the above-related case summary, a clinical investigation was performed.Referencing case (b)(4) the customer was advised by their sleep specialist to discontinue the use of the soclean.After discontinued use of the device, their skin cleared up.The customer received md intervention for their respiratory symptoms, they were prescribed antibiotics for allergies and the bronchiole infection.The customer did not return their device.After consulting with our customer care department and being advised of non-compatible materials they believed materials used in the pap mask were the cause of the rash.The mask being used was over 10 years old and was only replaced after having the rash symptoms.They now use their new pap mask with a cloth liner on the outside that is sold by cpap equipment suppliers.The customer uses the soclean without placing the mask into the device.They are using sanitary wipes daily on the mask as well as hand washing weekly with unapproved soap, (b)(6).All symptoms are resolved, and the customer continues to use their soclean device against md recommendation without further reported issues.Soclean has reviewed and made improvements to our complaint handling procedure to ensure compliance with fda regulations.These improvements were recommended as a result of an internal audit conducted by an external independent regulatory consultant.We revised our decision trees and re-evaluated retrospective complaints to ensure reportable events were correctly identified.Per fdas guidance soclean is now reporting these retrospective mdrs.In addition, soclean has opened several capa's to remediate the audit findings.

Event Description

Customer reports unspecific respiratory problems, cough and rash with md intervention requiring antibiotics and an allergy medication.

• Brand Name: SOCLEAN 2
• Type of Device: SLEEP EQUIPMENT MAINTENANCE SYSTEM
• Manufacturer (Section D): SOCLEAN, INC.; 12 vose farm road; peterborough NH 03458
• Manufacturer (Section G): SOCLEAN, INC.; 12 vose farm road; peterborough NH 03458
• Manufacturer Contact: anne nadeau ; 12 vose farm road; peterborough, NH 03458 ; 6033712533
• MDR Report Key: 12587128
• MDR Text Key: 275199841
• Report Number: 3009534409-2021-00175
• 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: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SC1200
• Device Catalogue Number: SC1200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other