MAUDE Adverse Event Report: BESTMED DTT THERMOMETER

Model Number KD 2201

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 02/17/2016

Event Type  malfunction  

Event Description

Thermometer wouldn't read temp.

• Brand Name: DTT THERMOMETER
• Type of Device: DTT THERMOMETER
• Manufacturer (Section D): BESTMED
• MDR Report Key: 5455009
• MDR Text Key: 38861012
• Report Number: MW5060422
• 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: 02/18/2016

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
• Device Lot Number: KD 2201
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 59