MAUDE Adverse Event Report: BLEPHEX, LLC BLEPHEX TREATMENT; SPONGE, EYELID CLEANING, POWERED

Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Patient tried and failed medication.

• Brand Name: BLEPHEX TREATMENT
• Common Device Name: SPONGE, EYELID CLEANING, POWERED
• Manufacturer (Section D): BLEPHEX, LLC
• MDR Report Key: 11900957
• Report Number: MW5101615
• Device Sequence Number: 10951938
• Product Code: PYU
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2021
• Patient Sequence Number: 1