MAUDE Adverse Event Report: CVS CVS HEALTH FLEXIBLE TIP DIGITAL THERMOMETER

Device Problem Incorrect Measurement (1383)

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

Event Date 02/08/2018

Event Type  malfunction  

Event Description

When my son fell ill last night, i was not able to get a reasonably accurate temperature read when trying to do so on two brand new cvs health digital flexible tip thermometers that i purchased from a local (b)(6) store just two weeks ago.All readings were in the 96-97 degrees range.When i tested the thermometers on myself last night while not ill, i could not get a reading over 97 degrees.My normal temperature is 98.5-98.7.This is a frightening product issue that could result in death or serious complications when consumers are relying on this thermometer to decide how to treat illness and determine if emergency care is needed during flu season.

• Brand Name: CVS HEALTH FLEXIBLE TIP DIGITAL THERMOMETER
• Type of Device: DIGITAL THERMOMETER
• Manufacturer (Section D): CVS
• MDR Report Key: 7266532
• MDR Text Key: 100121922
• Report Number: MW5075199
• Device Sequence Number: 0
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 52