MAUDE Adverse Event Report: SIGHT SCIENCES, INC. TEARCARE; EYELID THERMAL PULSATION SYSTEM

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

Patient Problems Fatigue (1849); Rash (2033); Arthralgia (2355); Cough (4457); Unspecified Eye / Vision Problem (4471)

Event Date 09/27/2021

Event Type  Injury  

Event Description

Patient had a procedure on a machine called tearcare and had a severe facial rash develop and eye issues, and then very shortly after had systemic symptoms of fatigue, cough, joint pain.Fda safety report id # (b)(4).

• Brand Name: TEARCARE
• Type of Device: EYELID THERMAL PULSATION SYSTEM
• Manufacturer (Section D): SIGHT SCIENCES, INC.
• MDR Report Key: 14522235
• MDR Text Key: 292979594
• Report Number: MW5109964
• Device Sequence Number: 1
• Product Code: ORZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female