MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 3; SLEEP EQUIPMENT MAINTENANCE SYSTEM

Model Number SC1400

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Cough (4457); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/15/2022

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 clinical investigation was performed.The customer states preexisting lung cancer.It is important to note that the customer sees a pulmonary doctor for treatment of her lung disease.Due to a drop in oxygen saturation while using the soclean the customer saw the md and was given a pulmonary function test.No medication was used for treatment.It is not abnormal for a customer with preexisting conditions to receive lung function measurements on a regular basis.Continue to track and trend.

Event Description

Customer reports coughing, congestion and shortness of breath.Md seen.Received pulmonary function test and no new prescriptions.

• Brand Name: SOCLEAN 3
• 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: 15439479
• MDR Text Key: 300063747
• Report Number: 3009534409-2022-00571
• Device Sequence Number: 1
• Product Code: LRJ
• UDI-Device Identifier: 00858242007147
• UDI-Public: (01)00858242007147(21)
• 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: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SC1400
• Device Catalogue Number: SC1400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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