MAUDE Adverse Event Report: FOREHEAD THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

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

Patient Problems Irritation (1941); Pain (1994)

Event Date 06/26/2020

Event Type  Injury  

Event Description

I live in a residential health care facility.Staff member took my temperature using a forehead thermometer for first time.I was suspicious because the device seemed to be pressed.I felt a sensation of the laser pointer feature - the beam being rotated over my right eye about 4 times.I felt helpless in reacting since we were so close and she cleverly had a young staff member next to her writing down the temperatures on a clipboard.I had lowered my eyelids so the beam was rotating.Over the left quadrant of my right eye, about an hour later i noticed i think redness in that eye and then at night when i rubbed that eye i yelled out in pain.The other eye, no pain.The next few days my reaction to glare increased substantially.I went to the ophthalmologist and he confirmed some difference between my left and right eye.So my sensations, pain and reacting to glare were much worse than the anatomical difference the eye doctor observed.It was a deliberate act.She asked to take my temperature again 3 days later.I obviously refused.I went to my local precinct to try to get (b)(6) to hold the thermometer as evidence.Because of the virus situation we were not allowed into the precinct and had to speak to an officer outside.The officer eventually agreed to file a report, and i should call in 4 days.I called in but no sign of report.A few days later i called the precinct and officer advised me to call 911, and a patrol car would take the report.I did so but unfortunately the 2 officers refused to file a report.This means that the thermometer is not in police custody and i am unable to identify the brand name; device was very small and fit inside the staff members hand.Since then i have seen a small yellow thermometer in the hands of staff.It might be called procore but not definite.So i think this was a "foreseeable misuse" incident.Also i did some reasons and found out that the fda allows 5 milliwatts of power but the u.K.Only allows 1 milliwatt of power.If this is true then i feel the fda should reconsider and drop the maximum power allowed to be 1 milliwatt.The same as the (b)(6) due to covid-19.Fda safety report id# (b)(4).

• Brand Name: FOREHEAD THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• MDR Report Key: 10471602
• MDR Text Key: 205143960
• Report Number: MW5096327
• 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: Patient
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 118