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

Model Number SC1200

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/01/2023

Event Type  Injury  

Manufacturer Narrative

File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.The customer reported a persistent issue of bringing up phlegm daily, and this symptom coincided with the introduction of the bypass adapter.While the customer has sought medical attention, the treating physician is unaware of the customer's soclean usage.It is crucial to note the customer's extensive history of allergies, long-term use of nasonex, and pre-existing sensitivity to various scents.The onset of phlegm coincided not only with the use of the soclean but also with the introduction of a new resmed cpap, creating a complex scenario.Given the customer's existing conditions, environmental changes due to relocation, and the introduction of new equipment, it is plausible that the symptoms may have multiple contributing factors.The customer remains willing to use the soclean and expressed satisfaction with its long-term use.A clinical investigation should involve a comprehensive discussion with the customer, considering her medical history, environmental changes, and the specific timeline of symptom onset to discern potential contributing factors.

Event Description

Customer reports phlegm.Customer never discussed use of sc device with md.Treatment received: inhaler & gerd medication which did not subside the phlegm.

• 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: 18118491
• MDR Text Key: 327909721
• Report Number: 3009534409-2023-00051
• 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: 11/13/2023

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
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• 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