MAUDE Adverse Event Report: AROA BIOSURGERY LTD. RESTELLA; MESH, SURGICAL

Model Number	R20253-1018G
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Necrosis (1971); Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dhr review: restella resorbable polymer batch ert-9e01 was fabricated on 01 may 2019.The completed batch record was reviewed to assist this investigation.Forty-four devices were manufactured and released for sale.Qc release testing for the final batches were reviewed.All tests were carried out as per established testing procedures, the individual results from the required test were all within aroa's specification.Batch was approved to release based on the completion of correct manufacturing processes and satisfactory results of the quality testing on the final devices.This batch was released for commercial sale from may 2019.There are no other device complaints received from any other customers for this batch.Based on the investigation, there is no evidence showing a suspected association between the patient developing skin necrosis and infection and the use of the device from this restella batch.
Event or Problem Description
A patient underwent a unilateral (right) mastectomy, after which a 500cc allergan expander was implanted.Before implantation, the pocket was irrigated with chlorpactin and the skinflap treated with betadyne.Two restella 10x18.5cm resorbable contours were sewn together with 3-0 monocryl and attached to the expander tabs.The expander tabs and some of the restella were attached to the chest wall.A blake drain was placed medially and along the imf and the skin flap closed.The incision was covered with gauze and tegraderm.On (b)(6) 2019 the expander and restella were removed due to dehiscence/exposure.There was noted skin necrosis and infection.

• Brand Name: RESTELLA
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): AROA BIOSURGERY LTD.; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• MDR Report Key: 8984595
• Report Number: 3007321028-2019-00014
• Device Sequence Number: 16212209
• Product Code: FTM
• UDI-Device Identifier: 09421905067058
• UDI-Public: 09421905067058
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K183398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: R20253-1018G
• Device Lot Number: ERT-9E01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention