Medical Device Complaint USA/CAN

Contact Person

Company Name

Email Address

Phone Number

Talee (cranial remoulding orthosis)

Talee Post-Op (cranial post-op synostosis orthosis)

Talee Protect (protective orthosis)

8sole (foot orthotics)

Piro (paediatric ankle foot orthosis)

Raptor Mask (protective face mask)

Augo (prosthetic socket)

Date / Time

Date

Device Quality (e.g. product break, crack, surface quality issue, colour quality issue, excessive wear)

Device Performance (bad fit, wrong trim-line, excessive pressure points, insufficient treatment outcomes)

Device Specification (e.g. wrong colour, wrong ankle joint type, wrong product type)

Product Safety (e.g. serious injury, serious product safety issue, reportable incidents)

General (e.g. late shipment, no tracking number, no response from support, packaging / labelling issue, other)

In case of product quality issue, always include photo documentation.

PDF, DOC, DOCX, PNG, JPG, JPEG, GIF file types only.

You can send additional photos to support@inventmedical.com

Yes - minor health problem, without long-term effect

Yes - long-term health damage

Yes - incident resulted in severe health damage or death

Yes