MAUDE Adverse Event Report: AROA BIOSURGERY RESTELLA; SURGICAL MESH

Catalog 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)
Date of Event	08/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a unilateral (right) mastectomy, after which a 500cc expander was implanted.Before implantation, the pocket was irrigated with chlorpactin and the skinflap treated with betadyne.Two restella devices were sewn together with 3-0 monocryl, covering the expander and attached to its tabs.The expander tabs 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 wound dressing.On (b)(6) 2019, about a week after surgery, the skin flap had developed necrosis and became infected.As a result the expander and its restella cover were removed.

• Brand Name: RESTELLA
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsford smith place; airport oaks; auckland, 2022 ; NZ 2022
• MDR Report Key: 8983935
• Report Number: 3010513348-2019-00004
• Device Sequence Number: 3330152
• Product Code: FTM
• UDI-Device Identifier: 09421905067058
• UDI-Public: 09421905067058
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2019
• Report Date (Section F): 08/26/2019

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 Catalogue Number: R20253-1018G
• Device Lot Number: ERT-9E01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/21/2019
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2019
• Initial Date Received by Manufacturer: Not provided
• 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
• Patient Age: 76 YR