MAUDE Adverse Event Report: ARC DEVICES USA, INC. ARC INSTA TEMP; THERMOMETER, ELECTRONIC, CLINICAL

Device Problems Burst Container or Vessel (1074); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 02/08/2019

Event Type  No Answer Provided  

Event Description

Caller is reporting that the thermometer battery exploded; it sounded like a loud gunshot.He stated that the was not sure where the noise came from at first or what had caused the explosion but he discovered that the case of the unit was blown open the following day.The mfr was not contacted as of yet.Caller stated that he is concerned that this thermometer which can be used for children as well poses a safety hazard and should be reported.Retailer: (b)(6).Retailer state: (b)(6).(b)(4).

• Brand Name: ARC INSTA TEMP
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): ARC DEVICES USA, INC.
• MDR Report Key: 8491731
• MDR Text Key: 141318984
• Report Number: MW5085634
• Device Sequence Number: 0
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• 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