International Medical Devices Database

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
2018-308
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/527060-fda-advisory-no-2018-308-public-health-warning-against-the-purchase-and-use-of-unregistered-medical-device-the-bang-ze-flex-freely-abacterila-flexible-fabric-bandage-50-20-box
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
The food and drug administration(fda) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical devices: fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device product has not gone through the registration process of the agency and has not been issued with proper authorization in the form of certificate of product registration... to continue reading, download attachment... attachments: fda advisory no. 2018-308.Pdf.

Device

Bang-Ze Flex Freely Abacterila Flexible Fabric Bandage

Model / Serial
Manufacturer
N/A

Manufacturer

N/A

Source
FDAP

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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Safety Alert for Bang-Ze Flex Freely Abacterila Flexible Fabric Bandage

What is this?

Device

Bang-Ze Flex Freely Abacterila Flexible Fabric Bandage

Manufacturer

N/A