TECHNOVIGILANCE

To report a Technovigilance (TV) event locally (Costa Rica), as well as to report any problems that may take place with the medical devices distributed, please proceed to send an email to any of the following contacts:

• Gerencia general: gabyalvarez@altrebo.com
• Correo general de la empresa: info@altrebo.com

To report an event

Important information to include:

1. Date of the event. 
2. Patient Identification: Name, ID, sex, age and weight. 
3. Detailed description of the event:
   • Date of the incident.
   • Type of report (first time or follow up).
   • Type of event (Effect on the patients’ health or malfunctioning of the device).
   • Describe with detail the incident including, if applies, lab tests and any other tests and relevant medical history. 
4. In case of hospitalization or medical intervention: indicate the admission and release dates, file number and medics treating the patient. 
5. Name of the device, including model, batch number and expiration date. If applies, include the applied doses – for glues.
   • Was the issue resolved? Indicate taken actions. 
   • Was the cause detected? Explain. Indicate the reasons for the use of the device. 
   • Is this device invasive or not? 
   • Indicate if the effect stopped after discontinuing use. 
   • Indicate if the effect reappeared after reinstating use. 
   • Did you use other devices with the defective medical device? If affirmative, please provide details. 
6. Taken measures by medical personnel including any possible application of drugs or treatments to reduce effect. 
7. Report number if the case was submitted to Costa Rica’s Health Department. 
8. Information for the person that reports the case: Complete name, role, email and phone number.