MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN2; D2 SLEEP EQUIPMENT MAINTENANCE SYSTEM

Model Number SC1200

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Date 03/30/2020

Event Type  Injury  

Manufacturer Narrative

File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation a capa was opened by the company as a result of an independent internal audit that took place in february 2020.Capa (b)(4) involved a retrospective review of all customer cases to determine if they met the definition of a complaint.There is a portion of complaints that were miscategorized when they were created by customer care and at the time the determination was made that the complaints were not considered health related and/or potentially reportable.Therefore, these devices were not identified as needing functional and visual inspections.Given the scope and size of this retrospective project, it took a significant amount of time to review all of the cases and the devices we not identified timely and are no longer available for testing.Soclean still conducted an inspection of the details surrounding the complaints to the best of our ability and has reported anything that met the definition of reportable.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

Skin rash, the dermatologist gave a cream and the md suggested discontinued use of the soclean device.

• Brand Name: SOCLEAN2
• Type of Device: D2 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: 12530632
• MDR Text Key: 273314474
• Report Number: 3009534409-2021-00205
• 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: 09/24/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Initial Date Manufacturer Received: 03/30/2020
• Initial Date FDA Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2019
• 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