Details of the product
Product Name
*
Item number on Product/ Packaging
*
Manufacturer
*
LOT/ Serial Number
*
UDI
*
Number of units
*
Details of the client
Client-No.
Name/Company
*
Contact person
*
Street/Number
*
Zip Code/Residence
*
Phone number
*
-
Area Code
Phone Number
E-Mail
*
Details of the Feedback
Feedback Type
*
general Feedback(e.g. performance of device, customer service support, feedback about Nouvag AG)
Technical Support (e.g. device specific requests via phone)
preventive Maintenance / Service Activities (e.g. wear and tear, replacement of wearing parts)
STK (safety check)
Complaint (e.g. defect of the device, no functionality, failure/malfunction of device during surgery, failed to meet specifications, incident or adverse event) etc…
Detailed description
*
Attachments: (e.g. pictures,videos etc.)
Dateien durchsuchen
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Details of the complaint
Is a replacement needed?
*
Yes
No
Defect detection
*
Before shipping
After shipping
Before application
During application
After application
Not known
When did the event occur? Date of event [yyyy-mm-dd]
*
-
Year
-
Month
Day
Date
When did you get aware of the event? Awareness date [yyyy-mm-dd]
*
-
Year
-
Month
Day
Date
Did the event/malfunction lead to serious deterioration of health of patient/user/third party?
*
Yes
No
Not known
If yes, please describe:
*
Could the event/malfunction that occurred have led to serious harm to patients, users or third parties?
*
Yes
No
Not kown
If yes, please describe:
*
Did the event/malfunction lead to a significant delay in surgery?
*
Yes
No
Not known
If yes, please state how long was the delay? (min)
*
Description of the event/malfunction
*
Please describe the event as much in detail as possible
Is the product available for investigation/analysis?
*
Yes
No
Not known
If no, reason:
*
If “yes“, please compile "hygiene status and declaration of contamination" – defective product
*
Autoclave
Disinfection
Not known
Has an competent authority been notified?
*
Yes
No
Not known
If yes, please specify to which competent authority this was reported
*
If yes, please enter the date of the submission to the competent authority
*
-
Jahr
-
Monat
Tag
Attachments:(e.g., copy of the report to the competent authority, pictures, etc.)
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Name of Complainant/initiator
*
Date
*
-
Year
-
Month
Day
Signature
*
Submission date
-
Jahr
-
Monat
Tag
Datum
Stunde Minuten
Please verify that you are human
*
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