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Product Complaint

BellaFill, Amplifine PRP and Silhouette Instalift

For all other product complaints, please email [email protected]

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Suneva Sales Rep name:

Type 'NA' if unknown

Date of Event:

Physician Name:

Contact Person at the Account:

QAD Account Number:

Account Name:

Address:

Country:

Account Contact Telephone Number:

Account Contact Email Address:

Quantity of Product Reported:

Product Brand:

Bellafill

Bellafill Complaint Type

Bellafill Products (Syringe Issue)

Please complete the fields below to receive product replacements. “N/A” if not applicable.

Product Lot Number and Expiration Date:

Date Issue Was First Observed:

Description of Issue:

Note: For the Description of Issue, please provide as much information as possible, including appearance of product within the syringe.

Was the product used?

If yes, Is the patient okay and over 21 years?

Was the Bellafill treatment finished with another syringe?

What size needle was used?

How were the syringes brought to room temp and for how long?

What is the temperature of the fridge where Bellafill is stored?

Has product been warmed more than once?

Are the syringes stored in the product kit tray?

Are the syringes stored/used first in/first out?

If appearance-related, were other syringes in same kit okay?

If fill volume-related, Fill in mls?

If fill volume-related, is there product in the tip of the syringe?

Are images available?

Yes

No

Unknown

Image Upload

Max. file size: 512 MB.

Form completed by:

Date:

Bellafill Products (Adverse Event)

Please complete the fields below to receive product replacements. “N/A” if not applicable.

Product Lot number and expiration date:

Description of Issue:

Note: For the Description of Issue, please provide as much information as possible, including appearance of product within the syringe.

Patient Initials or Name:

Patient Age/Birthdate:

Quantity of syringes:

Injection Date:

Date of Onset:

Bellafill Skin Test Date:

Is this related to a clinical trial? If so, which one?

Has the patient had any other fillers or facial treatments in the affected area (other than Bellafill)?

Are there any concomitant conditions? Any meds?

Has any treatment been started? If so, what?

Would the account like to discuss with a Medical Affairs Advisor?

Yes

No

Are images available?

Yes

No

Unknown

Image Upload

Max. file size: 512 MB.

Form completed by:

Date:

Amplifine PRP and/or Centrifuge

Please complete the fields below to receive product replacements. “N/A” if not applicable.

Description of Issue:

PRP Tube – Model #:

PRP Tube – Lot #:

Appearance of PRP tube and/or contents?

Centrifuge – Model # / Brand:

Centrifuge – Serial Number:

Centrifuge Settings:

Counterbalance used?

Appearance of centrifuge?

Are images available?

Yes

No

Unknown

Image Upload

Max. file size: 512 MB.

Form completed by:

Date:

Silhouette Instalift

For all defective product or replacements, the fields below should be completed.

Suneva Reference Number:

Product details:

SMS:

Lot number and expiry date:

Treatment Date with Silhouette Instalift:

Date Issue Was First Observed:

Description of Issue:

Are images available?

Yes

No

Unknown

Image Upload

Max. file size: 512 MB.

Form completed by:

Date:

Name

This field is for validation purposes and should be left unchanged.

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