MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 3; SLEEP EQUIPMENT MAINTENANCE SYSTEM

Model Number SC1400

Device Problem Insufficient Information (3190)

Patient Problems Rash (2033); Skin Burning Sensation (4540); Localized Skin Lesion (4542)

Event Date 03/07/2022

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

The customer reported a red rash, inflammation, open sores/discomfort along with what he described as a chemical burn on his face where the mask touched.The md was seen and prescribed an ointment.After treatment the customer is back to his baseline health.The customer reports sensitive skin at baseline.In addition it is important to note that the customer used the soclean device for the total of a week and did not maintain handwashing techniques per our ifu.

• Brand Name: SOCLEAN 3
• 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: 13997215
• MDR Text Key: 293850424
• Report Number: 3009534409-2022-00520
• Device Sequence Number: 1
• Product Code: LRJ
• UDI-Device Identifier: 00858242007147
• UDI-Public: (01)00858242007147(21)
• 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: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SC1400
• Device Catalogue Number: SC1400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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