MAUDE Adverse Event Report: SO CLEAN, INC. SOCLEAN2; D2 SLEEP EQUIPMENT MAINTENANCE SYSTEM

Model Number SC1200

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Dry Eye(s) (1814)

Event Date 09/15/2021

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

Dry eye, md prescribed a special medicine to put in eyes every night.

• Brand Name: SOCLEAN2
• Type of Device: D2 SLEEP EQUIPMENT MAINTENANCE SYSTEM
• Manufacturer (Section D): SO CLEAN, INC.; 12 vose farm road; peterborough NH 03458
• Manufacturer (Section G): SO CLEAN, INC.; 12 vose farm road; peterborough NH 03458
• Manufacturer Contact: anne nadeau ; 12 vose farm road; peterborough, NH 03458 ; 6033712533
• MDR Report Key: 12782452
• MDR Text Key: 280573445
• Report Number: 3009534409-2021-00368
• 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: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Date Manufacturer Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2020
• 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