MAUDE Adverse Event Report: CONAIR LLC. CONAIR; THERMOMETER

Model Number ITH94F

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 02/14/2024

Event Type  malfunction  

Event Description

2/20/2024 - the consumer claims the temperature on the device was not accurate.The temp was 98.2 when other thermometers were 103.4 when taking the temp on her son.The consumer accepted a replacement.

Manufacturer Narrative

3/11/2024 - the consumer accepted a replacement and will not be returning the device to the manufacturer.Therefore, an investigation will not occur.

• Brand Name: CONAIR
• Type of Device: THERMOMETER
• Manufacturer (Section D): CONAIR LLC.; 1 cummings point rd.; stamford CT 06902
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902
• MDR Report Key: 18873586
• MDR Text Key: 337302820
• Report Number: 1222304-2024-00005
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ITH94F
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1