MAUDE Adverse Event Report: CVS HEALTH (180 INNOVATIONS) / 180 INNOVATIONS LLC FLEXIBLE TIP DIGITAL THERMOMETER (5 SECOND READING); THERMOMETER, ELECTRONIC, CLINICAL

Model Number	KD-1760
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
False readings on device; while providing home care to elderly patient, a brand new cvs health-branded digital thermometer provided inconsistent and questionable temperature readings.Replaced the battery with a fresh one, problem appeared to resolve for several hours and then returned.(b)(6) search revealed many identical or similar problems with these thermometers, indicating a potential manufacturing quality problem.Fda safety report id# (b)(4).

• Brand Name: FLEXIBLE TIP DIGITAL THERMOMETER (5 SECOND READING)
• Common Device Name: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): CVS HEALTH (180 INNOVATIONS) / 180 INNOVATIONS LLC
• MDR Report Key: 10224014
• Report Number: MW5095338
• Device Sequence Number: 3373848
• Product Code: FLL
• UDI-Device Identifier: 00050428250440
• UDI-Public: (01)00050428250440
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 06/30/2020

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
• Operator of Device: Other
• Device Model Number: KD-1760
• Device Lot Number: 2004
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 49