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

Model Number SC1200

Device Problem Insufficient Information (3190)

Patient Problems Cough (4457); Nodule (4551); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/06/2022

Event Type  Injury  

Event Description

The customer was advised by her md last year to discontinue use of the soclean.At that time the customer was experiencing clear sinus drainage and a heavy cough.The customer did not follow md instructions and continued to use the soclean device.The customer's symptoms continued to get worse.She went to the md recently and was told she has a pulmonary nodule in the right lung.The cause of the nodule is unknown and further testing is being performed.The customer received a nebulizer and ct scan to diagnose the nodule.No further tests have been performed at this time.Since, the customer has discontinued use without improvement of symptoms.It is not unreasonable to assume that the nodule is unrelated to the soclean device and that the breathing issues/chest discomfort is related to the nodule.

Manufacturer Narrative

File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.The customer was advised by her md last year to discontinue use of the soclean.At that time the customer was experiencing clear sinus drainage and a heavy cough.The customer did not follow md instructions and continued to use the soclean device.The customer's symptoms continued to get worse.She went to the md recently and was told she has a pulmonary nodule in the right lung.The cause of the nodule is unknown and further testing is being.

• 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: 14914492
• MDR Text Key: 295229986
• Report Number: 3009534409-2022-00546
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 07/05/2022
• Supplement Dates Manufacturer Received: 06/06/2022
• Supplement Dates FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2020
• 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: Female