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    Field Safety Corrective Action

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    hitham shehata
    This document is a field safety corrective action report submitted to a national competent authority. It contains administrative information about the submitting organization and manufacturer. It also includes details about the medical device such as its class, model and serial numbers. The report describes the reason for the field safety corrective action, the actions to be taken by distributors and users, and the progress and time schedule for implementing the corrective actions. It lists the countries affected by the action within the European Economic Area and Switzerland.

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    © All Rights Reserved
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    Field Safety Corrective Action

    Uploaded by

    hitham shehata
    31 views4 pages
    This document is a field safety corrective action report submitted to a national competent authority. It contains administrative information about the submitting organization and manufacturer. It also includes details about the medical device such as its class, model and serial numbers. The report describes the reason for the field safety corrective action, the actions to be taken by distributors and users, and the progress and time schedule for implementing the corrective actions. It lists the countries affected by the action within the European Economic Area and Switzerland.

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    Field_Safety_Corrective_Action

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    Field_Safety_Corrective_Action

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    This document is a field safety corrective action report submitted to a national competent authority. It contains administrative information about the submitting organization and manufacturer. It also includes details about the medical device such as its class, model and serial numbers. The report describes the reason for the field safety corrective action, the actions to be taken by distributors and users, and the progress and time schedule for implementing the corrective actions. It lists the countries affected by the action within the European Economic Area and Switzerland.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    31 views4 pages

    Field Safety Corrective Action

    Uploaded by

    hitham shehata
    This document is a field safety corrective action report submitted to a national competent authority. It contains administrative information about the submitting organization and manufacturer. It also includes details about the medical device such as its class, model and serial numbers. The report describes the reason for the field safety corrective action, the actions to be taken by distributors and users, and the progress and time schedule for implementing the corrective actions. It lists the countries affected by the action within the European Economic Area and Switzerland.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 4

    F/QP-29-04 Rev.

    0
    Page 1 of 4

    Field Safety Corrective Action


    ----------------------------------
    1. Administrative information
    Name of national competent authority (NCA)

    Address of national competent authority

    Type of report
     Initial report
     Follow up report
     Final report
    Date of this report

    Reference number assigned by the manufacturer

    Incidence number and name of the coordinating national competent authority (if applicable)

    Identify to what other NCAs this report was also sent

    2. Information on submitter of the report


    Status of submitter
     Manufacturer
     Authorized representative within EEA, Switzerland and Turkey
     Others (identify the role):

    3. Manufacturer information
    Manufacturer name

    Manufacturer's contact person

    Address

    City Postal code

    Fax Phone

    Country E-mail

    4. Authorized representative information


    Name of the authorized representative

    The authorized representative's contact person

    Address

    City Postal code

    Fax Phone

    Country E-mail
    F/QP-29-04 Rev.0
    Page 2 of 4

    5. National contact point information


    National contact point name

    Name of the contact person

    Address

    City Postal code

    Fax Phone

    Country E-mail

    6. Medical device information


    Class
     AIMD Active implants

     IVD Annex II List A  MDD Class III


     IVD Annex II List B  MDD Class IIb
     IVD Devices for self-testing  MDD Class IIa
     IVD General  MDD Class I

    Nomenclature system (preferable GMDN)

    Nomenclature code

    Nomenclature text

    Commercial name/brand name/make

    Catalogue number Model number


    Serial number(s) and/or Lot/batch number(s)

    Software version number (if applicable)

    Manufacturing date / Expiry date (if applicable)

    Accessories / associated device (if applicable)

    Notified body (NB) ID-number

    7. Description of FSCA
    Background information and reason for the FSCA

    Description and justification of the action (corrective/preventive)

    Advice on actions to be taken by the distributor and the user

    Progress of FSCA , together with reconciliation data (Mandatory for a Final FSCA)
    F/QP-29-04 Rev.0
    Page 3 of 4

    FSN status Attached please find


     Draft  Field Safety Notice (FSN) in English
     Final  FSN in national language
     Others (please specify):
    Time schedule for the implementation of the different actions

    These countries within the EEA and Switzerland are affected by this FSCA
    Within EEA, Switzerland and Turkey:

     ES  EE  DK  DE  CZ  CY  CH  BU  BE  AT
     LT  LI  IT  IS  IE  HU  GR  GB  FR  FI
     SI  SE  RO  PT  PL  NO  NL  MT  LV  LU
     TR  SK

    Candidate Countries:
     HR
     All EEA, Candidates Countries, Switzerland and Turkey

    Others:

    8.Comments

    I affirm that the information given above is correct to the best of my knowledge.

    ……………………………………..
    Signature

    Name City Date

    Note: Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or
    authorized representative or the national competent authority that the content of this report is complete or
    accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or
    contributed to the alleged death or deterioration in the state of the health of any person.

    AT=Austria, BE= Belgium, BU=Bulgaria, CY= Cyprus, CZ= Czech Republic, DK=Denmark, ES=
    Estonia, FI= Finland, FR= France, GB= Germany, GR= Greece, HU= Hungary, IE= Iceland (EFTA), IS=
    Ireland, IT= Italy, LV = Latvia, LI= Liechtenstein (EFTA), LT= Lithuania, LU= Luxembourg, MT= Malta,
    NL= Netherlands, NO= Norway (EFTA), PL= Poland, PT= Portugal, RO= Romania, SE= Slovenia, SI=
    Slovakia, Spain, Sweden, Switzerland(EFTA), TR= Turkey(Candidate), United Kingdom.
    F/QP-29-04 Rev.0
    Page 4 of 4

     ES  EE  DK  DE  CZ  CY  CH  BU  BE  AT
     LT  LI  IT  IS  IE  HU  GR  GB  FR  FI
     SI  SE  RO  PT  PL  NO  NL  MT  LV  LU
     SK

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