MAUDE Adverse Event Report: SOCLEAN, INC SOCLEAN2; SLEEP EQUIPMENT MAINTENANCE SYSTEM

Model Number SC1200

Device Problem Insufficient Information (3190)

Patient Problems Sneezing (2251); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/01/2021

Event Type  Injury  

Event Description

The customer experienced sneezing, congestion and cold like symptoms.

Manufacturer Narrative

The root cause and injury cannot be traced to the device as no return was made.No permanent impairment to the body function or system is noted.

Manufacturer Narrative

The root cause and injury cannot be traced to the device as no return was made.No permanent impairment to the body function or system is noted.

Event Description

The customer experienced sneezing, congestion and cold like symptoms.

• Brand Name: SOCLEAN2
• Type of Device: SLEEP EQUIPMENT MAINTENANCE SYSTEM
• Manufacturer (Section D): SOCLEAN, INC; 12 vose farm road; peterborough NH 03458
• Manufacturer (Section G): SOCLEAN, INC; 12 vose farm road; peterborough NH 03458
• Manufacturer Contact: anne nadeau ; 12 vose farm road; peterborough, NH 03458 ; 6033712533
• MDR Report Key: 13062227
• MDR Text Key: 285225693
• Report Number: 3009534409-2021-00482
• 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: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• 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: 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Male