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

Model Number SC1400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blister (4537)

Event Date 03/08/2022

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

Customer reports bilsters on nose and mouth.Md prescribed the antibiotic keflex and advised customer to stop using the soclean.

• Brand Name: SOCLEAN 3
• Type of Device: SLEEP EQUIPMENT MAINTENANCE SYSTEM
• Manufacturer (Section D): SO CLEAN, 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: 13999208
• MDR Text Key: 288798993
• Report Number: 3006534409-2022-00523
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2022

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: SC1400
• Device Catalogue Number: SC1400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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