Draft Workflow

Incoming Communication

Patient Complaint — Discomfort During Catheter Procedure — Subject 07-006

Received: 13 Mar 2026 15:45 UTC

Site: 07 — Hospices Civils de Lyon

From: Claire Dupont (Study Coordinator)

Classification

Complaint

Channel: email | Direction: in

Text Block Suggestions

1st — Complaint Acknowledgment to Site

Dear {{CONTACT_NAME}}, Thank you for reporting the product complaint related to the VascuPath 3F Interventional Cathete...

Score: 1.60 | Category match: CAT-COMP; Phase match: any; Language match: en

formality=formal (+0.15); detail_level=thorough (+0.10)

2nd — Complaint Investigation Initiation

Dear {{CONTACT_NAME}}, This letter confirms that a formal investigation has been initiated for the product complaint su...

Score: 1.60 | Category match: CAT-COMP; Phase match: any; Language match: en

formality=formal (+0.15); detail_level=thorough (+0.10)

3rd — Complaint Follow-Up Request

Dear {{CONTACT_NAME}}, We are following up on the product complaint submitted by {{SITE_NAME}} (Site {{SITE_NUMBER}}), ...

Score: 1.50 | Category match: CAT-COMP; Phase match: any; Language match: en

formality=formal (+0.15)

Draft Response

Dear Claire Dupont,

Thank you for reporting the product complaint related to the VascuPath 3F Interventional Catheter at Hospices Civils de Lyon (Site 07).

Your complaint has been logged in the MedCore Clinical Research complaint management system and assigned the following reference:

Complaint Reference: {{COMPLAINT_ID}}
Date Received: 16 Mar 2026
Device Lot Number: {{LOT_NUMBER}}

Our quality assurance team will conduct a preliminary assessment within five business days to determine the nature and scope of the reported issue. You will be notified of the investigation outcome and any required corrective actions.

In the meantime, please retain the affected device and any associated packaging in its current condition. If the device has been used in a study procedure, please document any observed deviations from expected performance in the subject's case report form and source documentation.

If you believe this complaint is associated with a serious adverse event or poses an immediate risk to subject safety, please also submit an SAE report in accordance with Section 9.4 of the study protocol PMCF-2024-CAT-001.

Kind regards,
Sarah Mitchell
Clinical Research Associate
MedCore Clinical Research

Resolved 6 placeholder(s)

Unresolved: LOT_NUMBER, COMPLAINT_ID