MAUDE Adverse Event Report: FRIDABABY LLC. FRIDABABY 3-IN-1 TRUE TEMP DIGITAL THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

Device Problem High Test Results (2457)

Patient Problems Distress (2329); Alteration in Body Temperature (4568)

Event Date 05/16/2021

Event Type  Injury  

Event Description

My baby is (b)(6) old.On sunday (b)(6), she had been a little fussier than usual, but no other symptoms of sickness, so i watched her closely and gave her extra cuddles, likely going through the 8 week growth spurt.She was still her smiley self and eating just fine.I took her temperature with the fridababy 3-in-1 true temp digital thermometer because my husband mentioned he had a little sinus pressure and a running nose, feeling a little off.When taking her temp, this product by fridababy registered at 100.3.A temp of 100.4 in an infant is an emergency, as they're too little to have such a high temperature and are at risk for seizures.I called her doctors office and the on-call nurse said she must go to the emergency room if she reaches a temperature of 100.4 or higher.After this product by fridababy fluctuated between low 99 and 100 every hour throughout the day, around dinner time this product registered 100.5, so off to the emergency room we went.My daughter had to get extensive lab testing done to make sure she wasn't at risk for meningitis (potential spinal tap) and other illnesses.You can imagine how much my heart broke seeing my child like this and unable to hold or comfort her.Three needle pricks (one in each hand and one on her foot) and a nose swab later, i was finally able to hold her for the 6 hours that the lab lost her bloodwork, had to get it redone and finally went home around 1am.Her discharge temp taken by medical professionals with the hospital grade thermometer was 98.7.We followed up with her pediatrician on monday(b)(6) 2021.Before we went to the appointment, i took her temperature again and this fridababy product registered her temperature at 100.2, and i started to worry because another fever means the emergency room round two.We arrived at the doctors office, and her temp was a low 99.Again, showing no other signs of sickness and doctor saying she sounds and looks great, we went home.I began to be suspicious something was up with our thermometer because i was the only one registering a high temperature for my daughter using the fridababy thermometer, she had not registered a 100.4 or higher fever at the hospital or at her doctors office.On our way home, i stopped into (b)(6) to grab another thermometer.When we got home, i used both back to back on my daughter and the (b)(6) brand registered 99.0 and 15 seconds later, this fridababy thermometer registered 100.0 (both taken rectally).A whole degree difference.The latest (b)(6) reviews hold true to this product and after going back and reviewing the latest reviews, i am not the only one who's baby was sent to the emergency room because of the inaccuracy of this product by fridababy.Many other parents are registering a whole degree off or more with this thermometer.Almost every most recent review on amazon are similar stories to ours above: (b)(6) i respectfully ask that this product be tested and/or be taken off the product shelves, as it is causing many parents, like myself, panic that their baby has a dangerously high fever and causing unnecessary emergency room visits.The attached photo is an example of the inaccuracy of the fridababy product (registered 99.8), comparing to the cvs branded child's thermometer (registered 98.5).This temperature was taken today (b)(6) of my daughter (both rectally) 15 seconds apart.Fda safety report id# (b)(4).

• Brand Name: FRIDABABY 3-IN-1 TRUE TEMP DIGITAL THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): FRIDABABY LLC.
• MDR Report Key: 11862334
• MDR Text Key: 252338110
• Report Number: MW5101477
• Device Sequence Number: 1
• Product Code: FLL
• 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: 05/19/2021

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 1 MO
• Patient Weight: 5