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Report of Serious (Product) Events and Adverse Reactions – WMDA 2019

Reporting institution and type of report

Dear S(P)EAR contact person,

WMDA is developing a new system to collect SEAR/SPEAR, which will make it possible to prepare informative annual reports, analyse this important data more extensively, and improve communication between WMDA and the person reporting the incident. If you would like to be be a pilot user for the new system, please contact Esther Pustjens by e-mail (esther.pustjens@wmda.info). The pilot period will be from May 1 till July 1, 2019.

In anticipation of this new system, this form should be used from 1 Januari 2019.
 
Together with the development of the new reporting system, we also evaluated and adjusted the workflow of the S(P)EAR committee and the WMDA office. Mirjam Fechter is currently working as a medical consultant for WMDA. She will review all reported incidents and will provide reporting organisations feedback on their incident.

We are excited about these developments and we would appreciate receiving your feedback at 
sear-spear@wmda.info. Please let us know if any questions are unclear, missing or not relevant.

Thank you for submitting your incidents to us.
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9. What is the type of report? 


Harm to a donor:

Choose this category to report an adverse reaction in a donor during or after a donation procedure. You can also use this category to report other negative consequences for the donor, such as unnecessary procedures. This category is comparable to what was previously called a ‘SEAR’.

Harm to a recipient:

Choose this category to report an adverse reaction in a recipient during or after the infusion of a cell product. You can also use this category to report any harm in a recipient as a consequence of product quality issues, delay in delivery etc. This category is comparable to what was previously called a ‘SPEAR’.

Risk of harm:

Choose this category to report any problem or incident that could have had (but did not have) negative consequences for the donor or the recipient or the system (as a whole).

In case of harm to donor: long term or short term?