Scribd Logo
Upload

Welcome to Scribd!

  • 4K views

    REG.8.2-01-03 Post-Market - Surveillance - Report

    Uploaded by

    MarcBenetPozo
    This document is a post-market surveillance report for the MOWOOT II medical device. It provides information on the number of units sold, complaints received, adverse events, vigilance reports, and recalls. It also describes any risks identified and assessments of whether the device is performing as intended.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd

    REG.8.2-01-03 Post-Market - Surveillance - Report

    Uploaded by

    MarcBenetPozo
    4K views4 pages
    This document is a post-market surveillance report for the MOWOOT II medical device. It provides information on the number of units sold, complaints received, adverse events, vigilance reports, and recalls. It also describes any risks identified and assessments of whether the device is performing as intended.

    Original Description:

    Post-Market_Surveillance_Report

    Original Title

    REG.8.2-01-03 Post-Market_Surveillance_Report

    Copyright

    © © All Rights Reserved

    Available Formats

    DOCX, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This document is a post-market surveillance report for the MOWOOT II medical device. It provides information on the number of units sold, complaints received, adverse events, vigilance reports, and recalls. It also describes any risks identified and assessments of whether the device is performing as intended.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    4K views4 pages

    REG.8.2-01-03 Post-Market - Surveillance - Report

    Uploaded by

    MarcBenetPozo
    This document is a post-market surveillance report for the MOWOOT II medical device. It provides information on the number of units sold, complaints received, adverse events, vigilance reports, and recalls. It also describes any risks identified and assessments of whether the device is performing as intended.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    You are on page 1of 4

    REV: 1

    Post-Market Surveillance Report Code:


    Version: X REG.8.2-01-03 Revision Date:
    Last modification: DD.MM.YYYY October 2019

    Product name: MOWOOT II

    Legal manufacturer name: usMIMA S.L.

    Legal manufacturer address: Avinguda Cornellà 142, 3-4,


    08950 Esplugues de Llobregat, Barcelona

    Medical Device Classification: Class IIa

    Applicable Regulation: MDR 2017/745

    Date of CE Mark:

    Date device was commercialised:

    Critical Suppliers: Proline Barcelona


    Mego Afek AC LtD

    Report Date Reviewed by Date of Review

    PMS Report 2019

    PMS Report 2020

    PMS Report 2021

    PMS Report 2022

    POST MARKET SURVEILLANCE REPORT

    Date the product went on the market

    Number of units sold

    Number of complaints

    Complaint rate (Complaints/units sold)

    Have there been any trends identified in relation to


    complaints

    Number of adverse events

    Were there any unforeseen risks

    REG.8.2-01-03 Pág. 1/4


    REV: 1
    Post-Market Surveillance Report Code:
    Version: X REG.8.2-01-03 Revision Date:
    Last modification: DD.MM.YYYY October 2019

    Number of Vigilance reports to Competent Authority

    Vigilance report rate

    Number of reportable incidents

    Number of product recalls EU

    In case of CAPA’s or recalls, please give details below:

    REG.8.2-01-03 Pág. 2/4


    REV: 1
    Post-Market Surveillance Report Code:
    Version: X REG.8.2-01-03 Revision Date:
    Last modification: DD.MM.YYYY October 2019

    SECTION 1: DETAILED DESCRIPTION OF COMPLAINTS

    Classification description of complaints:

    Please Indicate in each event if the complaints were due to:

    Desktop Device Mal Function Device Change MI to MII


    Exoperistaltic Belt Mal Function Delivery issues
    Power Supply Mal Function Customer Support
    Size Change

    Are there any new emerging risks? Yes No

    Discuss new risks (if Applicable):

    Discuss Product Recalls (if Applicable):

    REG.8.2-01-03 Pág. 3/4


    REV: 1
    Post-Market Surveillance Report Code:
    Version: X REG.8.2-01-03 Revision Date:
    Last modification: DD.MM.YYYY October 2019

    SECTION 2: VIGILANCE REPORTING

    Has a vigilance report been sent to a Competent Authority? Yes No

    Has a vigilance report sent to Notified Body? Yes No

    Please list all vigilance report with identifier number:

    If yes, discuss each report in detail and provide copies of the reports, if not already submitted to N.B.:

    SECTION 3: RISK MANAGEMENT

    Has the risk management file been updated to reflect these Yes No
    events?

    Has the CER been updated to reflect these events? Yes No

    Does the benefit of the product still outweigh the risk taking Yes No
    account “State of the Art”?

    SECTION 4: PERFORMANCE

    Is the device performing as intended, in line with the design Yes No


    of the device?:

    REG.8.2-01-03 Pág. 4/4

    You might also like