MAUDE Adverse Event Report: BABYLY MEDICAL DEVICE CO LTD THERMOMETER, ELECTRONIC, CLINICAL

Device Problem Defective Device (2588)

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

Event Date 04/10/2020

Event Type  malfunction  

Event Description

Consumer purchased digital thermometer on (b)(6).Consumer did not know product was manufactured in (b)(4).The thermometer arrived and did not work properly.There were no instructions for use.Manufacturer: babyly medical device co ltd, (b)(4) shipper: (b)(4).(b)(4).

• Brand Name: THERMOMETER, ELECTRONIC, CLINICAL
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): BABYLY MEDICAL DEVICE CO LTD; 768 changidan road; yiwu 32200 ; CH 32200
• MDR Report Key: 9967561
• MDR Text Key: 188282937
• Report Number: MW5094161
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1