Supplier name: *
Healthcare facility name: *
Address and contact name: *
Contact e-mail address: *
IDENTIFICATION OF THE PRODUCT
Product name(s): *
Product order code(s): *
Lot number(s): *
If you have experienced similar problems with this product before (other lot), enter batchnumber(s) here:
Check box if the complained product(s) will be returned to FertiPro (FertiPro NV - Industriepark Noord 32 - 8730 Beernem - Belgium)
Description of the problem
Detailed description of the problem: *
Actions taken by the reporter or healthcare facility involved including investigation or testing? *
Was the problem detected after the first application of the product. * NO YES
Estimation of the severity of the problem, in terms of possible hazard to the gamete / embryo / patient: * Negligible Inconvenience Significant Unknown
IN CASES OF DEVIATING PRODUCT APPEARANCE OR DECREASED PRODUCT PERFORMANCE
Storage conditions at the distributor: 2-8°C 2-25°C May have been between < 2°C or >25°C for a while
Product was stored in the dark or in a cardboard box at the distributor
Transport from distributor to healthcare facility: Normal There was deviation Unknown
Specifiy if a deviation occured:
Describe the storage conditions at healthcare facility (if known):
Has the product been modified in any way (e.g. aliquoted, re-sterilized, ...), if so describe:
Recent change in disposable lab ware or other equipment in conjunction with the device?
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)? Yes No
Only for devices requiring CO2 incubation Which CO2 percentage was used in the failed procedure?
Have there been CO2 percentage or temperature fluctuations?
Other deviations? Specify:
I have read and accept the FertiPro privacy policy *
6 + 1 = ? Bewijs a.u.b. dat u een mens bent door de volgende vergelijking op te lossen. *
