MAUDE Adverse Event Report: BEST MED LLC / K-JUMP HEALTH CO., LTD. DIGITAL TEMPLE THERMOMETER (DTT); DTT THERMOMETER, ELECTRONIC

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460)

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

Event Date 09/19/2017

Event Type  No Answer Provided  

Event Description

Digital temple thermometer reading lower than normal body temperatures.

• Brand Name: DIGITAL TEMPLE THERMOMETER (DTT)
• Type of Device: DTT THERMOMETER, ELECTRONIC
• Manufacturer (Section D): BEST MED LLC / K-JUMP HEALTH CO., LTD.
• MDR Report Key: 6879543
• MDR Text Key: 87047720
• Report Number: MW5072242
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1