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Report a problem

In order for us to deal with your problem in an accurate and efficient manner, please fill out all the information you have available in the form below and send it to us.

Required fields are marked with a "*"
N/A: Not available

CONTACT DETAILS
*Supplier name: N/A
*Healthcare facility name:
N/A
*Address and contact name:
*Contact e-mail:
IDENTIFICATION OF THE PRODUCT
*Product name(s):
*Product code(s):
*Lot number(s):
*Did you ever have similar problems with this product before (other lot)? YES, Specify: NO
*Return of complained product(s) to FertiPro
(FertiPro NV
Industriepark Noord 32
8730 Beernem
Belgium)
Not possible Possible
DESCRIPTION OF THE PROBLEM
*Detailed description of the problem:
*Actions taken by the reporter or healthcare facility involved including investigation or testing? YES, Specify: NO
*Was the problem detected before the first application of the product? YES NO
*Estimation of the severity of the problem, in terms of possible hazard to the gamete / embryo / patient:

Specify:
IN CASES OF DEVIATING PRODUCT APPEARANCE OR DECREASED PRODUCT PERFORMANCE
Storage conditions at distributor:
Stored in the dark, or in a cardboard box
Transport from distributor to healthcare facility: Deviation, Specify:
Normal Unknown
Storage conditions (at healthcare facility): Describe:
Unknown
Has the product been modified in any way (e.g. aliquoted, re-sterilized, ...)? YES. Specify:
NO Unknown
Recent change in disposable lab ware or other equipment in conjunction with the device? YES. Specify:
NO Unknown
Experience level of the user with the product New user Limited experience Longterm user
How long has the product been opened before the problem was first detected?
How many successful procedures have been performed with the same sales unit(s)/bottle(s) before the problem was detected (frequency of use)?
In how many procedures did the contested lot fail?
Has the product been used according to the instructions for use? If not, specify how the used protocol is different.
In case of failed fertilization or embryo development or harm to the patient
Relevant patient history
For devices which are supplied sterile.
Has the product been opened and handled aseptically (e.g. in an ISO5 LAF-bench)?
Only for devices requiring CO2 incubation
Which CO2% was used in the failed procedure?


Have there been CO2% or temperature fluctuations?


Other deviations?

Verification code:

Resources

Click on the link below to request a certificate of analysis, or to send feedback to FertiPro N.V.