insufficient

Appendix D – Determine Further Escalation of 027-WI186 Rev E – Complaint Investigation

Appendix F – Determine Further Escalation of 027-WI186 Rev E – Complaint Investigation

Existing Corrective Action / Inv

Foreseen in risk/included in Monitoring

Insufficient information

Existing Corrective Action / Inv

Foreseen in risk/included in Monitoring

Insufficient information

for known events when there is no sufficient info available such as Serial/lot # and the device is not returned for analysis to determine the most likely cause.

Let us escalate first to TL/SME

no prod return, broad allegation, no lot/ serial and product ID