MAUDE Adverse Event Report: BEST MEDICAL LLC BESTMED TEMPORAL THERMOMETER

Model Number KD2201

Device Problem Defective Component (2292)

Patient Problem Fever (1858)

Event Date 12/18/2017

Event Type  malfunction  

Event Description

I tried to use thermometer and was not working accurately.My daughter was burning up with a fever and i needed to know her temperature immediately and device was worthless.

• Brand Name: BESTMED TEMPORAL THERMOMETER
• Type of Device: BESTMED TEMPORAL THERMOMETER
• Manufacturer (Section D): BEST MEDICAL LLC
• MDR Report Key: 7137392
• MDR Text Key: 95506529
• Report Number: MW5074125
• 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: Other
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: KD2201
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 14