MAUDE Adverse Event Report: BESTMED LLC DIGITAL TEMPLE THERMOMETER

Model Number KD2201

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 12/20/2014

Event Type  malfunction  

Event Description

We purchased this digital temple thermometer and it was extremely inaccurate.

• Brand Name: DIGITAL TEMPLE THERMOMETER
• Type of Device: DIGITAL TEMPLE THERMOMETER
• Manufacturer (Section D): BESTMED LLC
• MDR Report Key: 4364763
• MDR Text Key: 5259218
• Report Number: MW5039797
• 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: Other
• Type of Report: Initial
• Report Date: 12/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: KD2201
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR