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Product Complaint

BellaFill, Amplifine PRP, Silhouette Instalift, and Avéli

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

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Sales Rep name:

Type 'NA' if unknown

Date of Event:

Physician/Clinician Name:

Contact Person at the Account:

Account Contact Telephone Number:

Account Contact Email Address:

Account Number:

Type 'NA' if unknown

Account Name:

Street address, City, State, Zip:

Country:

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?

Yes

No

Was there patient injury as a result of the reported issue?

Is the patient over 21 years old?

Yes

No

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 fill volume-related, what is the closest millilter based on the printed scale on the syringe(s)?

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: Please provide as much information as possible, including appearance of adverse event, size, and locations.

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?

(Is the appearance normal or is there any distortion or separation of the tube or contents?)

Centrifuge – Model # / Brand:

Centrifuge – Serial Number:

Centrifuge Settings:

Counterbalance used?

Appearance of centrifuge?

(Any damage to the centrifuge inside or out, any cord damage?)

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.

Model Number (starts with "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:

Avéli

Lot Number

Product model (e.g. AVE001, AVE002, etc.)

Description of issue:

Device available to be returned?

(if yes: please save the device, we will contact you for return instructions)

Yes

No

Patient initials

Patient weight (lbs)

Patient age / DOB

Patient Race / Ethnicity

Are images available

Yes

No

Unknown

Image Upload

Max. file size: 512 MB.

Email

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

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