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

Model Number SC1200

Device Problem Insufficient Information (3190)

Patient Problem Rash (2033)

Event Date 08/21/2023

Event Type  Injury  

Manufacturer Narrative

File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.It is important to note that the customer does not want to return the soclean device despite being offered an rma.The customer was not handwashing properly per our ifu.

Event Description

Customer reports breakout on face where mask comes in contact with the skin.A dermatologist seen.Received prescription strength cream.

• Brand Name: SOCLEAN 2
• 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: 17602251
• MDR Text Key: 321719606
• Report Number: 3009534409-2023-00040
• 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: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• 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: 08/21/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male