Medical Device Complication Intake Form
Use this form to report a medical device complication and provide the details needed for review and follow-up.
Patient and Reporter Information
Patient Full Name
*
First Name
Middle Name
Last Name
Patient Date of Birth
*
-
Month
-
Day
Year
Date
Best Contact Phone
Please enter a valid phone number.
Format: (000) 000-0000.
Best Contact Email
example@example.com
Reporter Name
First Name
Middle Name
Last Name
Preferred Contact Method
*
Please Select
Phone
Email
Either
Medical Device Details
Device Name
*
Model or Product Name
Manufacturer
*
Lot or Serial Number
Device Type
*
Please Select
Implant
Wearable
External Use
Other
How Was the Device Used?
*
Implanted
Worn
Used Externally
Complication or Adverse Event Details
Description of what happened
*
When did the complication start?
*
-
Month
-
Day
Year
Date
Hour Minutes
AM
PM
AM/PM Option
When was it first noticed?
*
-
Month
-
Day
Year
Date
Hour Minutes
AM
PM
AM/PM Option
Was medical attention sought?
*
Yes
No
Not sure
Severity
*
Please Select
Mild
Moderate
Severe
Critical
Unknown
Symptoms or problems experienced
Pain
Swelling
Bleeding
Infection signs
Shortness of breath
Nausea
Dizziness
Fever
Device malfunction
Other
Current status of the complication
*
Please Select
Resolved
Improving
Ongoing
Worsened
Is the complication ongoing?
*
Yes
No
Unknown
Actions Taken and Outcomes
Actions Taken
*
Device stopped or disconnected
Device removed
Device adjusted or reprogrammed
Clinician contacted
Emergency care sought
Hospitalization
Monitoring only
Other
Outcome After Action
*
Resolved
Improving
Unchanged
Worsened
Unknown
Other
Is the Device Still in Use?
*
Yes
No
Unknown
Describe the Actions Taken
Describe Current Status or Ongoing Effects
Attachments and Follow-up
Upload Photos
Upload a File
Drag and drop files here
Choose a file
Cancel
of
Upload Medical Records
Upload a File
Drag and drop files here
Choose a file
Cancel
of
Upload Device Packaging
Upload a File
Drag and drop files here
Choose a file
Cancel
of
Permission to Contact You for Follow-up
*
Yes, I authorize follow-up contact about this report
No, please do not contact me
Submit Report
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