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CSC-F-002-Incident-Report-Template.md

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CSC-F-002-Incident-Report-Template.md

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qms_version 2.2.0
sop_id CSC PR.014
sop_version 2.0.1
template_id CSC F.002
template_version 2.0.1

Incident Assessment

General
Template ID CSC F.002
Template Version 2.0.1
QMS Version 2.2.0
SOP ID CSC PR.014
SOP Version 2.0.1
Regulatory References ISO 13485:2016 Section 8.2.3
Author
Approval

Report Information

Date dd/mm/yyyy
Reported by Name and Role
Datix incident report reference ID ID Number

General Event Description and Occurrence

Criterion: An event has occurred that could be considered a reportable incident.
Applicable? ( ) Yes ( ) No
Explanation: if no, describe why this is not applicable
Category of event

Relationship Between the Device and Event

Criterion: A (direct or indirect) causal relationship is suspected between the device and the event.
Applicable? ( ) Yes ( ) No
Explanation: if no, describe why this is not applicable

Event Outcomes

Criterion: The event led, or might have led, to one of the following outcomes:
Applicable? ( ) Yes ( ) No
Explanation: if no, describe why this is not applicable
Outcome: ( ) death of a patient, user or other person
( ) serious deterioration in state of health of a patient, user or other person

Template Copyright openregulatory.com. See template license.