MAUDE Adverse Event Report: ARC DEVICES USA, INC. ARC DEVICES LTD INSTATEMP THERMOMETER OF TOMORROW; THERMOMETER, ELECTRONIC, CLINICAL

Device Problem Explosion (4006)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/23/2019

Event Type  malfunction  

Event Description

The original batteries (brand is (b)(6)) exploded inside of the thermometer, causing it to fly apart with contents (lye) all over the inside of the medicine cabinet.All medications inside were penetrated with the sodium hydroxide and hydrochloric acid and had to be thrown out.This is a danger to children.I've seen many other reports on (b)(6) consumer comments.This could have exploded on a child's nightstand or when their temperature is being taken.Thermometer exploded.Fda safety report id# (b)(4).

• Brand Name: ARC DEVICES LTD INSTATEMP THERMOMETER OF TOMORROW
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): ARC DEVICES USA, INC.
• MDR Report Key: 8565790
• MDR Text Key: 143584466
• Report Number: MW5086283
• 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: Patient
• Type of Report: Initial
• Report Date: 04/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR