Product Complaint

BellaFill, Amplifine PRP, Silhouette Instalift, Avéli, Gel Implant, Gel Sizer, Saline Sizer, Tissue Expander, Viality, Tiger Guard, Tiger View, alloClae, Simpliderm, and Cannula Kit / control dispensers

" " indicates required fields

Sales Rep Name:

Type 'NA' if unknown

Sales Rep Email:

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

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

Is the patient over 21 years old?

Yes

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

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

Are images available?

Yes

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

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

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

Patient initials

Patient weight (lbs)

Patient age / DOB

Patient Race / Ethnicity

Are images available

Yes

Unknown

Image Upload

Max. file size: 512 MB.

Gel Implant, Gel Sizer, Saline Sizer, Tissue Expander

Type 'NA' if unknown or not applicable.

Product Details

Gel Implant

Gel Sizer

Saline Sizer

Tissue Expander

Patient Name

Patient Date of Birth

MM slash DD slash YYYY

Right side Model number / size:

Left side Model number / size:

Right side Serial Number / Lot number:

Left side Serial Number / Lot number:

Treatment date(s):

Onset date of issue:

MM slash DD slash YYYY

Description of issue:

Are images available

Yes

Unknown

Image Upload

Max. file size: 512 MB.

Viality, Tiger Guard, Tiger View, alloClae, Simpliderm, Cannula Kit / control dispensers

Type 'NA' if unknown or not applicable.

Product Details

Viality

Tiger Guard

Tiger View

alloClae

Simpliderm

Cannula Kit / control dispensers

Patient Name

Patient Date of Birth

MM slash DD slash YYYY

Model Number / size:

Serial Number / Lot number:

Lot number:

Expiry Date:

MM slash DD slash YYYY

Allograft ID(s):

Treatment Date(s):

Onset date of issue:

MM slash DD slash YYYY

Description of issue:

Are images available

Yes

Unknown

Image Upload

Max. file size: 512 MB.

Incision Size - Right

Incision Size - Left

Kind of Breast Implants

Shape

Round

Shaped / Anatomical

Texture

Smooth

Textured

Profile

Low Profile

Moderate Profile

High Profile

Size of Implant - Right

Size of Implant - Left

Hydration Method and Solution

Hydration Method

NO Hydration or Implants + solution pouring

Hydration Solution

Saline solution

Betadine / Iodine + antibiotics mix

Other

Trimming Line

Trimming Line Used - Right

Trimming Line Used - Left

Issue Details

Upload marked product diagram

Please download a copy of the Tiger Guard diagram, mark the area(s) related to the complaint with a circle, and upload the marked diagram.

Max. file size: 2 MB.

Detailed description of complaint

If two implants were inserted:

Time between the right and left implant insertion

During the time between the left and right implant insertion, did you seal the velcro as in the top image or leave it unfolded as in the bottom image?

Phone

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