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

Model Number SC1200

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Headache (1880); Memory Loss/Impairment (1958); Nasal Obstruction (2466); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/16/2021

Event Type  Injury  

Manufacturer Narrative

File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.

Event Description

On this date (08/16/2021) soclean received notification of a sus voluntary event report for mw5102759.Following our review of the complaint related to (headache, memory loss, fatigue, nasal irritation/congestion), soclean has determined that a medical device report (mdr) was required for this event.

• Brand Name: SOCLEAN 2
• 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: 12787377
• MDR Text Key: 284377848
• Report Number: 3009534409-2021-00274
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• 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: 08/16/2021
• 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