Medical Device Complaint

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1. Contact Information (Clinic) (Required.)

Contact Person

Company Name

Email Address

Phone Number

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2. Affected Device (Required.)

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)

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3. Device CN (Required.)

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4. Accident Date (Required.)

Date / Time

Date

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5. Accident type (Required.)

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)

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6. Description of accident (Required.)

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7. Documentation (photo / document)

You can send additional photos to support@inventmedical.com

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8. Customer Request (Required.)

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9. Did accident result in affecting patient's health? (Required.)

Yes - minor health problem, without long-term effect

Yes - long-term health damage

Yes - incident resulted in severe health damage or death

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10. If patient's health was affected, please provide more information here.

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11. Was this accident reported by you to Healthcare Authority? (Required.)

Yes

Medical Device Complaint

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* 1. Contact Information (Clinic) (Required.)

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* 2. Affected Device (Required.)

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* 3. Device CN (Required.)

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* 4. Accident Date (Required.)

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* 5. Accident type (Required.)

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* 6. Description of accident (Required.)

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* 7. Documentation (photo / document)

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* 8. Customer Request (Required.)

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* 9. Did accident result in affecting patient's health? (Required.)

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* 10. If patient's health was affected, please provide more information here.

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* 11. Was this accident reported by you to Healthcare Authority? (Required.)

1. Contact Information (Clinic) (Required.)

2. Affected Device (Required.)

3. Device CN (Required.)

4. Accident Date (Required.)

5. Accident type (Required.)

6. Description of accident (Required.)

7. Documentation (photo / document)

8. Customer Request (Required.)

9. Did accident result in affecting patient's health? (Required.)

10. If patient's health was affected, please provide more information here.

11. Was this accident reported by you to Healthcare Authority? (Required.)