MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. EAR AND FOREHEAD THERMOMETER

Model Number TH1003A

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Manufacturer Narrative

Based on the analysis, the thermometer is not accurate due to the dirty probe tip.After the purity of the device, can be measured accurately.

Event Description

The consumer claims the device was giving inaccurate measurements.The customer's grandmother had a fever and go to the hospital, then find the thermometer was giving inaccurate measurement.

• Brand Name: EAR AND FOREHEAD THERMOMETER
• Type of Device: EAR AND FOREHEAD THERMOMETER
• Manufacturer (Section D): SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.; no.3 building xilibaimang xush; industrial estate,518108; shenzhen, guangdong 51810 8; CH 518108
• Manufacturer (Section G): SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.; no.3 building xilibaimang xush; industrial estate,518108; shenzhen, guangdong 51810 8; CH 518108
• Manufacturer Contact: kang jianping ; block a, 5th floor, fuhua tech; no. 9116 beihuan road; shenzhen, guangdong 51810-8 ; CH 518108
• MDR Report Key: 6957392
• MDR Text Key: 90554586
• Report Number: 3005170249-2017-00017
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: TH1003A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other