MAUDE Adverse Event Report: K-JUMP HEALTH DTT; THERMOMETER

Model Number KD-2201

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Fever (1858)

Event Date 01/10/2016

Event Type  Injury  

Event Description

I bought my dtt thermometer 2 months ago at a local (b)(6) store and i had noticed the thermometer marking incorrectly, seeing as i took my son to the emergency room with what i thought was a 98.7 temperature and he was actually at 102.1.A few times i felt my son burning up and i didn't think there was anything wrong because the thermometer was marking a regular temperature.My baby is my everything and fevers in babies are serious.I need a new thermometer, this was an expensive thermometer that i thought would be more convenient and it has actually given me headaches.

• Brand Name: DTT
• Type of Device: THERMOMETER
• Manufacturer (Section D): K-JUMP HEALTH
• MDR Report Key: 5393977
• MDR Text Key: 36975614
• Report Number: MW5059643
• 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: 01/20/2016

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
• Device Model Number: KD-2201
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 MO
• Patient Weight: 7