Form for reporting suspected adverse incident by healthcare provider

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1. Administrative information

Name of National Competent Authority (NCA)

Address of National Competent Authority

Suspected adverse incident reference number assigned by SÚKL

2. Information about healthcare provider

Name

ID

Contact name

Address

City

Postcode

Phone

Fax

E-mail

Reference number assigned by healthcare provider (if applicable)

3. Medical device information

Kind of medical device (e.g.: implantable pacemaker, dialyzer, ventilator, ultrasound, infusion set, diagnostic tests, glucometer…)

Name of the medical device

Model Number(s)

Catalogue number(s)

Serial number(s)

Lot/batch number(s)

Software version number (if applicable)

Device manufacturing date (if known)

Expiry date (if applicable)

Number of defective medical devices

Implant date (for implants only)

Explant date (for implants only)

Duration of implantation (for implants only, to be filled if the exact implant or explant dates are unknown)

Accessories (if applicable)

Associated device (if applicable)

Does the medical device bear the CE marking?Yes
No

4. Manufacturer information

Name of manufacturer

Address (if known)

Country

5. Information about supplier

Name of supplier

6. Information about suspected adverse incident

Have you contacted the manufacturer?Yes
No

Manufacturer’s awareness date

Have you contacted supplier of medical device?Yes
No

Supplier’s awareness date

Date the incident occurred

Place of incident

Incident description

Number of patients involved (if known)

Number of medical devices involved (if known)

Is medical device available for analysis?Yes
No

Where?At the healthcare provider
Returned to the manufacturer
Returned to the supplier of medical device
Returned to the service organisation

Date

Please indicate service organisation

Date

Operator of the medical device at the time of incident (select one)Health care professional
Patient
Other

Specify:

Usage of the medical device (select from list below)Problem noted prior use
Initial use
Reuse of a single use medical device
Reuse of a reusable medical device
Re-serviced / refurbished
Other

Please specify:

Outcome of the incident on user or other person (if applicable)Death of user or other person
Serious deterioration in state of health of user or other person
Without deterioration of health
Other

Please specify:

7. Patient information

Patient outcome Death
Serious deterioration in the state of health with consequence
Without deterioration of health
Other

Please specify:

Have been any actions taken?Yes
No

Description of actions taken (actions taken by the healthcare provider or patient)

Age of the patient at the time of incident, if applicable

Gender, if applicableMale
Female

Weight in kilograms, if applicable

8. Comments

Any additional information that you believe are related to the incident