Manufacturer’s Incident Report Form

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1. Administrative information

Name of National Competent Authority (NCA)

Address of National Competent Authority

Date of this report

Reference number assigned by the manufacturer

Reference number assigned by NCA

Type of reportFinal report

Does the incident represent a serious public health threat?Yes
No

Classification of incidentDeath
Unanticipated serious deterioration in state of health
All other reportable incidents

Identify to what other NCAs this report was also sent

2. Information on submitter of the report

Status of submitterManufacturer
Authorised Representative within EEA, Switzerland and Turkey
Others

Identify the role:

3. Manufacturer information

Name

Contact name

Address

City

Postcode

Phone

Fax

E-mail

Country

4. Authorised Representative information

Name

Contact name

Address

City

Postcode

Phone

Fax

E-mail

Country

5. Submitter´s information (if different from section 3 or 4)

Submitter’s name

Contact name

Address

City

Postcode

Phone

Fax

E-mail

Country

6. Medical device information

Class

AIMD Active implants
MDD Class III
MDD Class IIb
MDD Class IIa
MDD Class I

IVD Annex II List A
IVD Annex II List B
IVD Devices for self-testing
IVD General

Nomenclature system (preferable GMDN)GMDN
UMDNS (ECRI)
EDMS

Nomenclature code

Nomenclature text

Commercial name/brand name/make

Model number

Catalogue number

Serial number range (if applicable)

Lot/batch number(s) (if applicable)

Software version number (if applicable)

Device Manufacturing date

Expiry date

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/associated device (if applicable)

Notified Body (NB) ID-number

7. Incident information

User facility report reference number, if applicable

Manufacturer’s awareness date

Date the incident occurred

Incident description narrative

Number of patients involved (if known)

Number of medical devices involved (if known)

Medical device current location/disposition (if known)

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

Identify the role:

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

Please specify:

8. Patient information

Patient outcome

Remedial action taken by the healthcare facility relevant to the care of the patient

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

Gender, if applicableMale
Female

Weight in kilograms, if applicable

9. Healthcare facility information

Name of the health care facility

Contact person within the facility

Address

City

Postcode

Phone

Fax

E-mail

Country

10. Manufacturer’s preliminary comments

Manufacturer’s preliminary analysis

Initial corrective actions / preventive actions implemented by the manufacturer

Expected date of next report

11. Results of manufacturer's final investigation

The manufacturer’s device analysis results

Remedial action/corrective action/preventive action/Field Safety Corrective Action

NOTE: In the case of a FSCA the submitter needs to fill in the Report Form Field Safety Corrective Action

Time schedule for the implementation of the identified actions

Final comments from the manufacturer

Further investigation

Is the manufacturer aware of similar incidents with this type of medical device with a similar root cause?Yes
No

Number of similar incidents

If yes, state in which countries and the report reference numbers of the incidents

Others:

12. Comments

Comments