MAUDE Adverse Event Report: CONAIR LLC. CONAIR LLC.; INFARED HEAD THERMOMETER

Model Number ITH93

Device Problem No Apparent Adverse Event (3189)

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

Event Date 01/21/2022

Event Type  malfunction  

Manufacturer Narrative

07/16/2023 - the consumer accepted a replacement device.Therefore, an investigation will not occur.

Event Description

7/16/2023 - the incident occured in a nursing home which could involved medical attentiion from the consumers physician.The consumer claimed the temperature was off and was show 86.85 degrees.

• Brand Name: CONAIR LLC.
• Type of Device: INFARED HEAD 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: 17330757
• MDR Text Key: 319626223
• Report Number: 1222304-2023-00017
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 74108437266
• UDI-Public: 74108437266
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ITH93
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other