MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD AVENT SMART EAR THERMOMETER AND PHILIPS EAR THERMOMETER; EART THERMOMETER

Model Number DL8740

Device Problems Invalid Sensing (2293); No Apparent Adverse Event (3189)

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

Event Type  Injury  

Event Description

Consumer claims the product shows the wrong temperature when compared to other similar products.

Manufacturer Narrative

The wrong manufacturer was inputted in error.The manufacturer included within this follow up report is correct.

Event Description

Consumer claims the product shows the wrong temperature when compared to other similar products.

Manufacturer Narrative

Follow-up report #1: the wrong manufacturer was inputted in error.The manufacturer included within this follow up report is correct.Follow-up report #2: the model name, event problem and evaluation codes were updated.Additionally, the product was tested by the manufacturer and the product tested in accordance to specifications.The false reading experienced by the consumer had resulted from the product's lack of cleanliness; as the product was soiled with earwax when returned from the consumer.Via the user manual, users are instructed to ensure the device is clean prior to use.

Event Description

Consumer claims the product shows the wrong temperature when compared to other similar products.

• Brand Name: AVENT SMART EAR THERMOMETER AND PHILIPS EAR THERMOMETER
• Type of Device: EART THERMOMETER
• Manufacturer (Section D): SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD; no.. 3 building xilibaimang; xusheng, industrial estate; nanshan, shenzhen, cn-44, 51810 8; CH 518108
• MDR Report Key: 6267014
• MDR Text Key: 65415641
• Report Number: 3009181561-2017-00001
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2017,12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DL8740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2017
• Distributor Facility Aware Date: 12/22/2016
• Event Location: Home
• Date Report to Manufacturer: 01/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1