Vigilance

Read below what to do in case a 3Shape product has caused/contributed to, harm to a person (a patient, operator, or bystander), or may have caused/contributed to death or hospitalization. Hospitalization is defined as “admitted” to hospital (in contrast to “outpatient”) or an overnight stay in the hospital.

Step 1

Collect information about the harm that occurred

When informing 3Shape about harm that has occurred with one of our products it is important to collect as many details as possible about the event — see below.

Name and phone number of the person who notifies 3Shape about the incident
Address of reseller of the device
Age, sex, and role of the injured person (for example, patient, operator, bystander)
Every important detail about the event, for example:
- Date and time of event
- The clinical purpose or use of the 3Shape product at the time the event occurred (for example, CBCT scan for third molar diagnosis, design of surgical guide for implant surgery, placing TRIOS 3 Wireless battery in charger)
- As detailed description as possible of what happened, what did the harmed person experience, what led up to the event
- Description about any medical care or intervention that has been taken (for example, first aid given, ambulance, admission to hospital, surgery, etc.).
- Health status of the injured person at the time of notification
Name, type, model and serial number of the 3Shape product involved
Any other equipment used in conjunction with the affected device

Please ask the caller to make a written confirmation of the above information within the same day.

Step 2

Forward the above information without delay to 3Shape Support

Step 3

How to escalate the case to 3Shape Support

It is of vital importance that 3Shape is informed without delay of all incidents with a 3Shape product which have caused/contributed to, harm to a person (a patient, operator, or bystander), or may have caused/contributed to death or hospitalization. Hospitalization is defined as “admitted” to hospital (in contrast to “outpatient”) or an overnight stay in the hospital.

Outside of 3Shape Support opening hours

For all incidents with a 3Shape product which have caused/contributed to death or hospitalization (please see above definition), submit a case to [email protected], contact any of the persons below and leave a message with your name, phone number and a short description of the issue.

EMEA

Dmytro Gerus, +38 067 102 6903

Step 4

Follow-up

If the reported incident is assessed as serious, the incident will be reported as required to relevant health authorities. Therefore, it is required that the reseller ensures proper follow-up on the reported case as requested by 3Shape and informs the dental clinic/laboratory why responding in due time is required.

3Shape will inform when the case has been closed and no further action is required.