MAUDE Adverse Event Report: CONAIR LLC. CONAIR; THERMOMETER

Model Number ITH94

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/29/2023

Event Type  malfunction  

Event Description

(b)(6) 2023 - the consumer claims the device read 103.2 and 2 minutes later 97.3.

Manufacturer Narrative

(b)(6) 2023 - the consumer did not provide their contact or address information.Therefore, we will be unable to obtain the device in order to conduct an investigation.

• 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: 18343926
• MDR Text Key: 330793799
• Report Number: 1222304-2023-00030
• 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: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ITH94
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other