MAUDE Adverse Event Report: WALGREENS WALGREENS BRAND INFRARED INSTANT EAR DIGITAL THERMOMETER

Device Problem Invalid Sensing (2293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2017

Event Type  malfunction  

Event Description

My daughter started to not feel well when we were away from home last night.I could tell she was getting hot.We went to (b)(4) to get tylenol and i decided to pick up a thermometer while we were there, choosing the (b)(4) brand infrared instant ear digital thermometer, which retails for $(b)(4).Sure enough, she did have a low-grade temperature, which we treated.This morning, my dad sent me the reviews of the thermometer (after having considered buying one for himself): (b)(4)-product.I was shocked.One hundred reviews and the average is one star.I think it's a relatively safe assumption that a 30 dollar thermometer should be accurate.We came home today and, with my daughter still running hot, i decided to test the (b)(4) thermometer against my trust braun ear thermometer.Three times, there was a 2-3 degree (or more!) difference.That means that my daughter's 101 temperature last night was actually closer to 104, or even higher.My daughter has a history of febrile seizures, it's appalling that you are still carrying this in your stores after the feedback it's clearly gotten.I will be returning this and urging the store manager at my local (b)(4) to pull it from their shelves.It's reckless and dangerous for (b)(4) to be carrying this.The 100 plus reviews stating this have been posted for more than two years.

• Brand Name: WALGREENS BRAND INFRARED INSTANT EAR DIGITAL THERMOMETER
• Type of Device: THERMOMETER
• Manufacturer (Section D): WALGREENS
• MDR Report Key: 6348779
• MDR Text Key: 68135235
• Report Number: MW5067996
• Device Sequence Number: 1
• Product Code: FLL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 02/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 5 YR
• Patient Weight: 22