MAUDE Adverse Event Report: DOREL JUVENILE GROUP, INC. SAFETY 1ST EASY READ EAR THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

Device Problem Low Readings (2460)

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

Event Date 01/08/2020

Event Type  Injury  

Event Description

Delayed medical advice.Safety 1st ear thermometers need to be pulled from all shelves and all parents need to remove them from their medicine cabinets immediately as they give false readings with a difference of 3 to sometimes 7 degree difference.This is a problem safety 1st is well aware of by consumer complaints on their own site, yet they continue to sell these faulty devices.Below is my personal experience.On (b)(6) 2020, i visited my doctor for what he diagnosed as possibly the flu since my son tested positive for the flu the day before.Concerned that we may be getting sick, i purchased a safety 1st brand ear thermometer to monitor my family's temps.It's very important to me that my children and i are well because we don't want to infect my mom whom we take care of and has a whole host of illnesses.She however also ended up with the flu and pneumonia yet she never had any fever or so i thought until her temp was taken in the emergency room.I was shocked to learn that she'd had a fever since i'd just taken it on the way to the emergency room.I just looked at it as it must have shot up on the way.I never thought anything was suspicious even though the thermometer was giving all of us an average reading of somewhere between 94 and 97 degrees.I thought that meant we were doing really well.It wasn't until a recent trip to pick up her meds that i thought something may be wrong with the thermometer.I hadn't been feeling well and thought i might be catching a cold or this corona virus so i took the thermometer with me everywhere to keep up with my temp.I took my temp right before getting out of the car to pick up her meds even though i knew the nurses would check it before allowing me to walk into (b)(6) to pick up her meds; my thermometer registered my temp at 94.6 their's said my temp was 98.7.Still good but now problematic because i had been relying on the safety 1st product to care for my family.I visited the safety 1st website to see if it could be a battery problem only to find out that nearly every person reviewing the product had the same problem, the thermometers were registering temps 3 to 5 degrees lower than actual temps.The problem is that the safety 1st products are marketed to parents for children.This product is not safe and they know it but aren't doing anything about it.Think about all the parents relying upon this product to care for their children.A 3 to 5 degree temp difference could be a life and death matter as it could mean a child has a 104 degree temp and not 99.This product needs to be pulled off the shelves immediately as parents may delay urgently needed care because the thermometer is telling them their child is okay.Fda safety report id # (b)(4).

• Brand Name: SAFETY 1ST EASY READ EAR THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): DOREL JUVENILE GROUP, INC.
• MDR Report Key: 9952842
• MDR Text Key: 187537084
• Report Number: MW5094100
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): Y
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 04/10/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Disability
• Patient Age: 53 YR