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

Model Number V912US

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Caustic/Chemical Burns (2549); No Information (3190)

Event Date 02/24/2019

Event Type  Injury  

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 she left her child unattended, to make breakfast for 30 minutes, during which time the child was left to play with the thermometer.According to the consumer, the child chewed on the cover of the thermometer "like a lollipop", and somehow opened the cover of the unit.In the process, the child removed the battery and accidentally swallowed it.The battery caused burns to the esophagus, and the child underwent several surgeries to repair damage to his esophagus from the incident.More medical intervention may be required.The instructions for use have clear warnings which state, "do not allow children to take their temperature unattended", "keep out of reach of young children, elderly and pets", as well as a clear instruction to "carefully replace the battery cover and, using a coin, tighten the cover".It is unclear to us how a securely tightened battery compartment could have been opened by a small child.Kaz usa, inc.Has requested that the product be returned for testing.

• Brand Name: VICKS
• Type of Device: DIGITAL THERMOMETER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough 01752
• Manufacturer (Section G): MICROLIFE CORP.; 9f, 431, ruiguang road, neihu; taipei district, taiwan china, 11492 ; TW 11492
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch boulevard; suite 300; marlborough 01752 ; 5084907236
• MDR Report Key: 8417166
• MDR Text Key: 138688336
• Report Number: 1314800-2019-00015
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V912US
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 13 MO