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

Model Number SC1200

Device Problems Defective Component (2292); Pressure Problem (3012)

Patient Problem Cough (4457)

Event Date 12/12/2023

Event Type  Injury  

Event Description

Customer reports a dry cough.Md was seen and advised the cx to discontinue use of the sc, to replace her cpap and ordered a ct scan.Md did not prescribe anything for the cough.

Manufacturer Narrative

File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.Submission for due diligence: the patient presents with a non-treatment-requiring dry cough.Following a clinical investigation, the patient discloses pulmonary scarring diagnosed through a ct scan.The etiology of the scarring remains unidentified, and the dry cough is progressively resolving.Notably, the medical transcript does not attribute the scarring to the use of soclean, and it is pertinent to acknowledge the patient's history of tobacco product consumption as a plausible contributor to the observed pulmonary scarring.

• 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 ; 9545403325
• MDR Report Key: 18418531
• MDR Text Key: 331597558
• Report Number: 3009534409-2023-00063
• 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: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• 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: 12/22/2023
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• 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): Disability
• Patient Sex: Female