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

Model Number SC1200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Asthma (1726); Dyspnea (1816); Fatigue (1849); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/30/2023

Event Type  Injury  

Event Description

The customer reports scratchy throat, watery/dry eyes, fatigue, nasal congestion and irritation of asthma symptoms included shortness of breath.The md was seen.The customer reports prescriptions such as flonase and specialty medications used to treat water/dry eyes and nasal congestion.

Manufacturer Narrative

File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.It is pertinent to acknowledge that the customer possesses preexisting allergies and has received a recent asthma diagnosis.The acquisition of the soclean device occurred in 2019, and its utilization transpired without purported symptoms until the notification of the recall.Non-compliance with the instructions for use (ifu), specifically pertaining to handwashing and filter replacement, was noted.The customer indicates that prescribed medications failed to alleviate the reported symptoms.This report is submitted as part of due diligence.It is not unwarranted to hypothesize that the customer's preexisting asthma and documented history of allergies may have played a role in the manifestation of symptoms.In addition, the customer reported this event on 11/30/23.Contact attempts were made to perform a clinical investigation however the customer did not return the call attempts until 1/9/2024.Clinical information was collected and reported 30 days post investigation.

• Brand Name: SOCLEAN 2
• Type of Device: SLEEP EQUIPMENT MAINTENANCE SYSTEM
• Manufacturer (Section D): SOCLEAN, INC.; 1 vose farm road; peterborough NH 03458
• Manufacturer (Section G): SOCLEAN, INC.; 1 vose farm road; peterborough NH 03458
• Manufacturer Contact: jessica wilson ; 1 vose farm road; peterborough, NH 03458 ; 6033712570
• MDR Report Key: 18546545
• MDR Text Key: 333280538
• Report Number: 3009534409-2024-00007
• 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: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• 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: 01/18/2024
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• 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
• Patient Sex: Male