MAUDE Adverse Event Report: BESTMED DIGITAL THERMOMETER

Model Number KD-220IL

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

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Temperatures seemed inaccurate.

• Brand Name: DIGITAL THERMOMETER
• Type of Device: DIGITAL THERMOMETER
• Manufacturer (Section D): BESTMED
• MDR Report Key: 5491667
• MDR Text Key: 40059926
• Report Number: MW5060821
• Device Sequence Number: 1
• Product Code: FLL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: KD-220IL
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR