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Mentor Complaint

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ECM MANUAL PRODUCT COMPLAINT INTAKE FORM MENTOR NORDICS

Has Complaint Been Submitted Before? *

DEMOGRAPHICS

SURGICAL NURSE INFORMATION

SURGEON INFORMATION

DISTRIBUTOR INFORMATION

PATIENT INFORMATION

Sex *
Year of Birth

EVENT INFORMATION

Does The Reported Information Resonably Suggest That One of The Company's Products or Product Instructions May Have?
If yes to any of the above, please provide details in the event description.
(Date first observed - If different from Procedure date)
When Did The Event Occur?
Størst tilladte upload: 268.44MB

PRODUCT LOCATION

Note: If yes to any of the below please provide details in the event description
Was The Product Used as Indicated on Label?
Was Infection Found?
Was There any Surgery Delay?
If yes, How Long?
Were There Any Patient Consequences?
If yes, Please explain
Available for Returned?

IMPLANTABLE DEVICE

Was the device replaced during surgery?

WHICH SITE WAS IMPLANTABLE DEVICE

Which side?

IMPLANT DEVICE LEFT SIDE

IMPLANT DEVICE RIGHT SIDE

PRODUCT LOCATION - MENTOR

Placement
Left side (Device A if unknown)
Surgical Approach
Left side (Device A if unknown)
Length Of Incision (cm)
Left side (Device A if unknown)
Final Fill Volume
Left side (Device A if unknown)
Baker Grade
Left side (Device A if unknown)
Placement
Right side (Device B if unknown)
Surgical Approach
Right side (Device B if unknown)
Length of Incision (cm)
Right side (Device B if unknown)
Final Fill Volume
Right side (Device B if unknown)
Baker Grade
Right side (Device B if unknown)

ADDITIONAL QUESTIONS

How Was This Issue Discovered or Diagnosed?
Procedure Name?
Outcome of The Adverse Event

COMPLAINT DECLARATION

By checking this box, I vertify that all Information that are known/ available has been disclosed. If any new information will be made available, the additional information will be submitted through CST or to designated CHU without further delay.