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Reporting an incident

If you suspect that Touchdose has contributed to, or could have contributed to, harm to a patient — or if Touchdose has behaved in a way you believe to be clinically unsafe — please report it to Dosium immediately.

How to report to Dosium​

Email: contact@dosium.com

In your report, please include where possible:

  • A short description of what happened.
  • The date and time of the event, and the deploying organisation and care setting.
  • The medication, indication, and patient parameters in scope at the time of the event (without identifying the patient).
  • A screenshot of the Touchdose screen at the point the issue occurred, where available.
  • Whether the patient came to harm, and any clinical follow-up actions that have been taken.

Response​

Dosium treats all suspected device incidents with urgency. We will acknowledge your report, investigate in accordance with our vigilance procedures under the Medical Devices Regulations 2002, and keep you informed of the outcome. Where appropriate, we will notify the Medicines and Healthcare products Regulatory Agency (MHRA) and the deploying organisation.

Reporting directly to the MHRA​

You may also report a suspected medical device incident directly to the MHRA via the Yellow Card scheme:

https://yellowcard.mhra.gov.uk/

Reports to the MHRA do not replace reports to Dosium; please report to both.

Internal reporting​

This does not affect any obligation you may have to report the event internally within your organisation, in accordance with local incident reporting procedures.