MAUDE Adverse Event Report: FAMIDOC TECHNOLOGY COMPANY LTD / FAMIDOC TECHNOLOGY CO., LTD NONCONTACT FOREHEAD THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

Model Number FDIR-V22

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

Patient Problems Unspecified Infection (1930); Alteration in Body Temperature (4568)

Event Type  malfunction  

Event Description

Incorrect info; famidoc noncontact forehead thermometer purchased on (b)(6).Consistently displayed readings from 97° to 97.9° during both sickness and health even when i knew i was running a fever and that my normal temperature was 98.6°.I checked the readings at two doctors' offices, and they were also in the 97.0° to 97.9° range so i thought perhaps my temperature had changed over the years.Then i became really suspicious when i had a bad infection, knew i was running a fever, but received the same readings.Purchased vicks oral digital thermometer.Bingo! immediately had readings that make sense, and my normal is 98.6°.Not only was the famidoc totally inaccurate, but so were the unknown brands used at the doctors' offices.Famidoc is made in (b)(6).The market is flooded with (b)(6) made thermometers that i am betting are inaccurate, and they are being used in doctors' offices and in many other applications.Fda safety report id# (b)(4).

• Brand Name: NONCONTACT FOREHEAD THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): FAMIDOC TECHNOLOGY COMPANY LTD / FAMIDOC TECHNOLOGY CO., LTD
• MDR Report Key: 11874884
• MDR Text Key: 252940571
• Report Number: MW5101522
• Device Sequence Number: 1
• Product Code: FLL
• 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: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FDIR-V22
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 86