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

Model Number SC1200

Device Problem Insufficient Information (3190)

Patient Problems Asthma (1726); Bronchitis (1752); Cough (4457); Wheezing (4463)

Event Date 06/08/2022

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 a new diagnosis of asthma, non productive cough, bronchitis, and wheezing.She has an extensive medical background including but not limited to neurological damage from a car accident.The customer was not willing to provide/conclude a full clinical investigation and disconnected our call.Therefore, i was unable to gather pertinent information regarding her use of the soclean.In addition to an inconclusive clinical investigation the customer declined to return the soclean unit.It is not unreasonable to assume that the customer's experience/injury is not directly correlated to the soclean usage.She has seen the md with what she states to be asthma from an unknown cause/source.Reporting for due diligence.

Event Description

The customer states a new diagnosis of asthma, non productive cough, bronchitis, and wheezing.She has seen the md with what she states to be asthma from an unknown cause/source.The customer received a nebulizer and inhaler.It is important to note that after discontinued use of the soclean the customer was still experiencing bronchitis and has an extensive history of preexisting medical conditions.Reporting for due diligence.

• 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: 14914686
• MDR Text Key: 295248706
• Report Number: 3009534409-2022-00545
• 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: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• 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
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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