Events

Safety Alert for Indoplas Infrared Ear Thermometer

According to Food and Drug Administration Philippines, this safety alert involved a device in Philippines that was produced by manufacturer #17352.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event Number
    2018-237
  • Event Country
    Philippines
  • Event Source
    FDAP
  • Event Source URL
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/525279-fda-advisory-no-2018-237
  • Notes / Alerts
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
  • Extra notes in the data
  • Reason
    Fda advisory no. 2018-237 lifting the advisory of indoplas infrared ear thermometer under fda advisory no. 2018-120 re: “public health warning against the purchase and use of the unregistered medical device product (indoplas infrared ear thermometer)” the food and drug administration (fda) informs the public that the advisory on the medical device product “indoplas infrared ear thermometer” under fda advisory no. 2018-120 dated 02 april 2018 is hereby lifted pursuant to the compliance of the market authorization holder to existing and applicable laws, rules, and regulations. the above-mentioned medical device product is registered with certificate of product registration no. mdr-06882 valid until 29 june 2019 under company indoplas philippines, inc. the issuance of this advisory shall not in any manner preclude this office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to existing laws, rules, and regulations. for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it. . attachments: fda advisory no. 2018-237.Pdf.

Device

Indoplas Infrared Ear Thermometer

Manufacturer

manufacturer #17352