Braile Biomédica

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Hospital information

Hospital:

 

Tax I.D.:

 

Address:

 

No:

 

District:

 

City:

 

Zip Code:

 

Country:

 

Doctor’s name:

 

Title:

 

E-mail:

 

Phone:

 

Fax:

 

Product information

Product’s name:

 

Serial / Lot Number:

 

Manufacturer:

 

Anvisa Registration Number:

 

Date of event:

 

Date of procedure:

 

Date of report:

 

Event and Description of the fact:



The use of the product followed the manufacturer's instructions?
Yes No



The event occurred during:
unpacking preparation product’s use withdrawal from the system post-procedure other


Patient information

Full name of the patient:

 


Gender    F


Full name of the patient's mother:

 

Race/Color:

 

Date of birth:

 

Age:

 

Medical Record Number:

 

SUS Card Number:

 

Diagnosis / Indication for Treatment:


The event led to prolongation of hospitalization? Yes No

What period?

 

The patient died? Yes No

Date:

 

Was there permanent damage? Yes No

If yes, please describe:

 

Was there a temporary damage? Yes No

If yes, please describe:

 

Were there additional interventions? Yes No

If yes, please describe:

 


Did some part of the product remain in the patient's body?
Yes No


If yes, please describe:


Current Status of the patient:


Additional Information

Was/will be the event reported to the authorities? ( If yes, please attach a copy of the report )    Yes No

Is the product available for investigation? Yes No

If no, reason:

 

Current location of the product:

 

Submit date:

 

Form completed by

Doctor Perfusionist Nurse Distribuitor/Representative* Other


* Company’s name:

 

* Federal Tax I.D:

 

Person in charge:

 

E-mail:

 

Phone:

 

Fax: