MAUDE Adverse Event Report: HANGZHOU SEJOY ELECTRONICS & INSTRUMENTS CO, LTD TOPCO; 10 SECOND FLEXIBLE TIP DIGITAL THERMOMETER

Model Number 87-736-001

Device Problem Low Readings (2460)

Patient Problem Fever (1858)

Event Type  Injury  

Event Description

It was reported that the digital thermometer was reading low.The thermometer was used on the reporter's (b)(6)-year-old son and displayed a reading of 94.7 repeatedly.The mother was concerned and expressed the child had symptoms, such as being sweaty, and the child was taken to the er.The er measured the child's temperature to be 104 f rectally.The reporter tried the unit in her armpit, and got a reading of 96.8 repeatedly.The unit was in service for less than a year.The device was returned and evaluated and was found to be functioning properly and appeared to be giving accurate temperature readings.The device will be sent back to the manufacturer for their verification.

• Brand Name: TOPCO
• Type of Device: 10 SECOND FLEXIBLE TIP DIGITAL THERMOMETER
• Manufacturer (Section D): HANGZHOU SEJOY ELECTRONICS & INSTRUMENTS CO, LTD; bldg 2, no.202, zhenzhong road; west lake economy & tech zone; hangzhou, 31003 0; CH 310030
• MDR Report Key: 9506946
• MDR Text Key: 179810518
• Report Number: 1422443-2019-00007
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2019

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: 87-736-001
• Device Catalogue Number: 87-736-001
• Device Lot Number: 59776010186163
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/18/2019
• Device Age: 13 MO
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 3 YR