MAUDE Adverse Event Report: ANDON HEALTH CO., LTD. INFRARED NO-TOUCH FOREHEAD THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

Model Number PT3

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This is regarding pt3 remote measurement products from ihealth lab and all the consumer products that have infrared light.All these products must clearly display that looking at the red light can damage your eyes.

• Brand Name: INFRARED NO-TOUCH FOREHEAD THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): ANDON HEALTH CO., LTD.
• MDR Report Key: 16818108
• MDR Text Key: 314096162
• Report Number: MW5117061
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/21/2023

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
• Device Operator: Other
• Device Model Number: PT3
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2023
• Patient Sequence Number: 1