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Manufacturer analysis

  1. Click on the Manufacturer Analysis section from the menu on the left:

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  2. Click on the plus sign next to Manufacturer’s preliminary comments:

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  3. Fill in all useful information in the three corresponding text fields:

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  4. Click on the plus sign next to Cause investigation and conclusion:

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  5. Select the appropriate option from the drop-down list:

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  6. Fill in the last three text fields of the IMDRF Component Codes section:

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  7. Click on the plus sign next to the following segment, i.e. Similar incidents:

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  8. Answer the first question on IMDRF code identification with Yes or No:

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    If you answered Yes, specify the Identification of similar incidents using IMDRF Adverse Event Reporting terms and codes:

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    If you answered No, type a description in the text box and provide in-house codes and terms to identify similar incidents in the corresponding fields shown below:

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  9. Provide information about the number of similar incidents and devices on the market:

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  10. Click on the plus sign next to Number of incidents:

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  11. Select the appropriate dates from the calendar buttons and fill out the number of incidents in each category:

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