PRODUCT SAFETY

Medical Device Reporting is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.
Mandatory reporters (i.e., manufacturers, device user facilities, and importers) are required to submit certain types of reports for adverse events and product problems to the FDA about medical devices. In addition, the FDA also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along with data from other sources, can provide critical information that helps improve patient safety. This section is dedicated to all physicians, patients and users involved with products presented by ThinKeen or discussed with ThinKeen while representing its manufacturing clients. We kindly invite physicians, patients and users to share and submit any information related to product safety and overall quality. ThinKeen is committed to collect these reports and to deliver them promptly to our clients (the manufacturer).

The submission can be performed by filling and sending the online form below or by clicking the e-mail button  on the left column of this page (please pecifiy the name of your organization in the message body).