MAUDE Adverse Event Report: DOREL JUVENILE GROUP SAFETY 1ST THERMOMETER (3 IN 1)

Model Number TH084

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 04/18/2017

Event Type  malfunction  

Event Description

My wife and i purchased a safety 1st thermometer at (b)(6) because our newborn felt warm.When tested, the thermometer read 100.6, which is very serious for newborn.I tested her gain, right away, and it read 100.4.Based on this, we had to take our daughter into the pediatricians office, who then directed us right away to the emergency dept at our local children's hospital.Although she didn't have a temperature in the pediatricians office, they had to take our word for it, that the thermometer at home read, 100.6.We had to spend 2 days in the hospital.Our newborn underwent a spinal tap, blood draw, iv and antibiotics.At no time did she has a high temperature in the hospital, but they had to follow protocol.After arriving back at home, i did some research and even bought other thermometers to compare.Two thermometers read a normal temp, while the safety 1st still at 100.9, 100.6 respectively.I did further research and read reviews on (b)(6) and found that others, more recently, have had the same issue with this thermometer.A few days later, i did the same testing with 3 of the thermometers and obtained the same result once again.I feel this batch is faulty/defective and needs to be taken off the market.At no time did our newborn actually have a temperature and because of that, she had to undergo unnecessary tests and antibiotics.

• Brand Name: SAFETY 1ST THERMOMETER (3 IN 1)
• Type of Device: THERMOMETER (3 IN 1)
• Manufacturer (Section D): DOREL JUVENILE GROUP
• MDR Report Key: 6553812
• MDR Text Key: 74891126
• Report Number: MW5069629
• Device Sequence Number: 0
• 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: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: TH084
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19 DA
• Patient Weight: 4