MAUDE Adverse Event Report: KAZ USA, INC., A HELEN OF TROY COMPANY VICKS; DIGITAL STICK THERMOMETER

Model Number V912US

Device Problem False Negative Result (1225)

Patient Problem Fever (1858)

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

Kaz usa, inc.Has requested that the product be returned to our company for testing, but it has not yet been received.

Event Description

A consumer reported that his thermometer had allegedly given (b)(6) readings on his child.The device allegedly gave readings that were 3.2°f lower than was later measured by a doctor.There were no complications from this incident, and the patient is doing well now.Kaz usa, inc.Had requested that the product be returned to our company for testing.

Event Description

A consumer reported that his thermometer had allegedly given false negative readings on his child.The device allegedly gave readings that were 3.2°f lower than was later measured by a doctor.There were no complications from this incident, and the patient is doing well now.

• Brand Name: VICKS
• Type of Device: DIGITAL STICK THERMOMETER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; 400 donald lynch boulevard; suite 300; marlborough MA 01752
• MDR Report Key: 12638534
• MDR Text Key: 276587713
• Report Number: 1314800-2021-00018
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00328785000276
• UDI-Public: 00328785000276
• Combination Product (y/n): N
• PMA/PMN Number: K043110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: V912US
• Device Lot Number: 07121ONB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 6 YR