Name of your organisation
Name of device (required)
Device Lot No.
Was the device intact and within its ‘Use By’ date when received?
Was the device used as intended and instructed in the IFU?
Describe nature of incident. (Please give as much details as possible. Do not disclose personal details or any other information which may identify individuals. If necessary, we will request this via direct communication).
What were clinician’s notes/observation?
What were patient’s comments/observation?