Vigilance form

Title *

Full name *

Job title *

Name of organisation/company *

Email *

Telephone number *

Reference

Are you a Corin employee? *

Yes

No

Please select the date that you were notified of the complaint/problem

Name of healthcare facility

Country in which event occurred *

Date event occurred

Unknown?

Event details *

Other

Please provide a comprehensive event description *

Date

Not applicable?

Unknown

Date

Not applicable?

Unknown

Number of devices involved *

As a result of this event was the surgery time extended? *

Yes

No

Not applicable

If 'yes', was the time by which the surgery was extended clinically relevant?

Yes

No

Not applicable

Is the item involved in the event still in use? *

Yes

No

Not applicable

Location of event *

Full Surgeon Name

Other

Was a technology used during this surgery? *

Yes

No

Unknown

Technology used

Was a technology used during the primary surgery? *

Yes

No

Unknown

Technology used

What was the impact to the patient? (Check all that apply) *

Disability or permanent damage

Extended hospitalisation

Frequency of patient monitoring increased

Not involving a patient

Patient(s) recalled for unscheduled check

Revision surgery required

Surgeon reverted to standard operating procedure without use of assistive technology

There was no impact to the patient

Other (please specify)

Other

Product Family *

Product description as labelled *

Part Number *

Lot Code / Serial No. *

UDI ref. if implant

Patient Case ID or First 3 Letters of Patient

Is device available to be returned to Corin? *

Yes

No

Unknown

Returnable device

Upload

Choose file

Product description as labelled

Part Number

Lot Code / Serial No.

UDI ref. if implant

Patient Case ID or First 3 Letters of Patient

Is device available to be returned to Corin?

Yes

No

Unknown

Returnable device

Upload

Choose file

Product description as labelled

Part Number

Lot Code / Serial No.

UDI ref. if implant

Patient Case ID or First 3 Letters of Patient

Is device available to be returned to Corin?

Yes

No

Unknown

Returnable device

Upload

Choose file

Product description as labelled

Part Number

Lot Code / Serial No.

UDI ref. if implant

Patient Case ID or First 3 Letters of Patient

Is device available to be returned to Corin?

Yes

No

Unknown

Returnable device

Upload

Choose file

Product description as labelled

Part Number

Lot Code / Serial No.

UDI ref. if implant

Patient Case ID or First 3 Letters of Patient

Is device available to be returned to Corin?

Yes

No

Unknown

Returnable device

Upload

Choose file

Product description as labelled

Part Number

Lot Code / Serial No.

UDI ref. if implant

Patient Case ID or First 3 Letters of Patient

Is device available to be returned to Corin?

Yes

No

Unknown

Returnable device

Upload

Choose file

How many photos / x-rays are attached

Attachment 1

Upload

Choose file

Attachment 2

Upload

Choose file

Attachment 3

Upload

Choose file

Attachment 4

Upload

Choose file

Attachment 5

Upload

Choose file

Are other relevant documents attached? (e.g. medical notes / usage ticket / log files)

Yes

No

Would you (and/or the customer) like to be informed of the results of our investigations? *

Vigilance Form

Section 1: Submitters details

Section 2: Complaint information

Event details (please check all that apply)

Date of implantation

Date of explantation

Section 3: Device information

Section 4: Associated device information

Product 1

Product 2

Product 3

Product 4

Product 5

Section 5: Additional information

Vigilance Form

Section 1: Submitters details

Section 2: Complaint information

Event details (please check all that apply)

Date of implantation

Date of explantation

Section 3: Device information

Section 4: Associated device information

Product 1

Product 2

Product 3

Product 4

Product 5

Section 5: Additional information

Cookie consent