MAUDE Adverse Event Report: K-JUMP HEALTH CO., LTD. CVS HEALTH FLEXIBLE TIP DIGITAL THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 50428

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2024

Event Type  malfunction  

Event Description

Over a period of 2 months, bought 3 (b)(6) health digital thermometers.Product: 5042842562, and lots: 2307 and 2306.The thermometers give readings that are 1-2 degrees lower than expected.We checked against our regular thermometers and had readings of 98 degrees f and higher vs 97 degrees and lower with the cvs thermometers.Distributed by 180 innovations denver, co and manufactured by k-jump health co, ltd in china.These thermometers are not properly calibrated and represent poor quality control.No harm to us, but we were provided 3 different thermometers as part of our (b)(6) program.Each time we complained they just gave another inaccurate thermometer.Reference reports: mw5153708, mw5153710.

• Brand Name: CVS HEALTH FLEXIBLE TIP DIGITAL THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): K-JUMP HEALTH CO., LTD.
• MDR Report Key: 19087526
• MDR Text Key: 340172485
• Report Number: MW5153709
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 50428
• Device Catalogue Number: 193592
• Device Lot Number: 2307
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2024
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White