Customer Complaint / Feedback Report Form

CUSTOMER COMPLAINT / FEEDBACK REPORT FORM

Important: Any/all written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a LifeCell or Allergan product after it is released for distribution is to be reported to Quality Complaints or Customer Solutions: Email: [email protected]

Complaint Reported By:

Reported By: LifeCell Employee Healthcare Provider Date Reported: Date Aware (LifeCell Employees Only):

Customer Information Section (DO NOT include patient name)

Complainant Name: Phone No: Email Contact Information: Institution Name: Phone No. (If diff.): Fax No. Address: City: State: Zip:

Product Information (Include multiple product types, if applicable)

Product Name:

Product Type (check all that apply): Human Revolve Porcine

Other Allergan Products (e. g. Implants, Sizers, Tissue Expanders)

Lot / Serial No.: Reorder No.: If more than one piece or additional products involved: Lot / Serial No.: Reorder No.:

Event/Complaint Description

Original Procedure and Date:

LIFECELL CORPORATION CONFIDENTIAL This document contains confidential and proprietary information of LifeCell Corporation. Any duplication or distribution of this document, or any use or disclosure of information it contains, without the prior consent of LifeCell is prohibited. LCF14.03.001.04 Rev. H 11/13/17 Page 1 of 2 CUSTOMER COMPLAINT / FEEDBACK REPORT FORM

Event/Complaint Description: (if applicable, include signs & symptoms; time from implant, type of implant or expander, complications, etc. If event happened during surgery, how was the surgery completed?)

If Patient Involved, Indicate the Following:

Patient Description: Male Female Age:

Contributing/related conditions: Diabetes Smoker Obese Other

If Other, describe: (e.g. multiple abdominal surgeries; prior MRSA infection, etc.):

Treatment:

Was Death or Injury Involved? No Yes

Current Condition/Outcome of Patient:

Was Product Explanted? No Yes

Will Product/Clinical Specimen be Returned to LifeCell? No Yes If Yes, notify Quality Complaints for MRA

Product Replacement Required? No Yes If Yes, notify Quality Complaints

No charge PO or attention line for replacement:

LIFECELL CORPORATION CONFIDENTIAL This document contains confidential and proprietary information of LifeCell Corporation. Any duplication or distribution of this document, or any use or disclosure of information it contains, without the prior consent of LifeCell is prohibited. LCF14.03.001.04 Rev. H 11/13/17 Page 2 of 2 LCF14.03.001.04

Revision History Record Revision LCR/ECR Effective Date A 1253 09/30/2002 B 1372 07/28/2003 C 1892 02/22/2006 D 2769 08/07/2008 E 3414 03/17/2010 F 4021/0365 08/04/2011 G 4467/0735 11/19/2012

Revision History Record Revision LCR/ECO Description of Changes Effective Date H 5991/2956 1. Updated the complaint email address. 11/13/17 2. Included reference to Allergan product throughout. 3. Removed reference to Strattice and Artia and replaced with Porcine. 4. Added reference to implants and expanders in Product Type. 5. Removed patient in Reported by. 6. Removed reference to Customer Solutions. 7. Clerical changes throughout.