MAUDE Adverse Event Report: AROA BIOSURGERY RESTELLA; SURGICAL MESH

Catalog Number R20153-2020G

Device Problem Insufficient Information (3190)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/04/2019

Event Type  Injury  

Event Description

A patient underwent a bilateral mastectomy with immediate prepectoral tissue expander reconstruction on (b)(6) 2019.The expanders were anteriorly covered with restella resorbable (pga).The patient presented with an infected (s.Lugdunesis) seroma in the left breast and the left expander and restella resorbable were removed on (b)(6) 2019 (39 days post op).The right side remained intact.

• Brand Name: RESTELLA
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsford smith place; airport oaks; auckland, 2022 ; NZ 2022
• MDR Report Key: 9413521
• MDR Text Key: 179611357
• Report Number: 3010513348-2019-00011
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 09421905067034
• UDI-Public: 09421905067034
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2019,12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: R20153-2020G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR