MAUDE Adverse Event Report: K-JUMP HEALTH CO., LTD. DTT DIGITAL THERMOMETER

Model Number KD 2201

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problem No Information (3190)

Event Date 12/05/2017

Event Type  Injury  

Event Description

I used this thermometer but never gave accurate reading, so i used another thermometer all the time to make sure.It never points out fever.Nothing serious happens as i checked on another thermometer but if i don't have another thermometer then something could happen to my baby and my other kids.Now i want to complain and call (b)(4) so no one answering and even no email is going to them.I spent $(b)(6), but it's not worth it."is there any way that i can get a replacement or my money back", i bought in usa but now in (b)(6).Please let me know.(b)(4).

• Brand Name: DTT DIGITAL THERMOMETER
• Type of Device: THERMOMETER
• Manufacturer (Section D): K-JUMP HEALTH CO., LTD.
• MDR Report Key: 7259305
• MDR Text Key: 99831797
• Report Number: MW5075138
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: KD 2201
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention