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

Model Number SC1200

Device Problem Defective Component (2292)

Patient Problem Skin Burning Sensation (4540)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.Soclean believes this complaint is related to the philips recall of the dreamstation 1, not the soclean device.Soclean is processing this complaint in accordance with its complaint handling and quality system processes.Reporting out of an abundance of caution, the customer failed to respond to 3 attempts to collect pertinent information regarding the potential underlying cause(s) of the adverse event.It remains uncertain whether the event is directly linked to the use of soclean.Reporting is conducted as part of due diligence.

Event Description

Customer reports soreness/burning on the inside of the nose.Md seen.Customer received unknown medication.

• 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: 18704390
• MDR Text Key: 335369227
• Report Number: 3009534409-2024-00020
• Device Sequence Number: 1
• Product Code: LRJ
• 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: 02/14/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• 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