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Click ‘Get Form’ to open the Medical Device Reporting form in the editor.
Begin with Section 1: Contact Information. Fill in the Date Reported, Dealer/Sales Representative Name, Contact Name, Title, Facility Name, Address, Phone, Email, and Fax. Ensure all fields are accurately completed for effective communication.
Move to Section 2: Product Information. Enter the Product Code(s) or provide a description if unknown. Include Lot Numbers and indicate if a picture of the sample is available. If applicable, specify whether samples will be returned for investigation.
In Section 3: Incident Information, document the Date of Incident and Number of Occurrences. Provide a detailed Description of Incident and select the General Issue Code. Include Patient Affected status and actions taken post-incident.
Complete Section 4: Catheter Specific Questions if relevant. Answer questions regarding site care solutions and infusion methods used during the incident.
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The Medical Device Reporting (MDR) Regulation requires medical device manufacturers, device user facilities and importers to establish a system that ensures the prompt identification, timely investigation, reporting, documentation, and filing of device-related death, serious injury, and malfunction information.
What are the mandatory reporting requirements for the FDA?
Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. (Key terms are defined in 21 CFR 803.3.) Instructions are available for completing the required 3500A form.
What are MDR reportable events?
An MDR reportable event is a death, a serious injury, or, if you are a manufacturer or importer, a malfunction that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
What is the MDR reporting?
Medical Device Reporting (MDR) 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.
What is MDR reportable?
(n) MDR means medical device report. (o) MDR reportable event (or reportable event) means: (1) An event that user facilities become aware of that reasonably suggests that a device has or may have caused or contributed to a death or serious injury or.
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People also ask
What is the FDA medical device reporting for manufacturers?
Mandatory Medical Device Reporting Requirements Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
What needs to be reported to the FDA?
When do you need to submit to the FDA? Initial reporting: Any suspected adverse events or any adverse events that are considered serious and unexpected must be reported to the FDA as soon as possible but no later than within 15 calendar days of first being notified of the event.
Related links
Overview of Medical Device Reporting
Describe FDAs regulatory authority for medical device reporting. Define MDR reportable event. Identify who reports to FDA and how.
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