MAUDE Adverse Event Report: AROA BIOSURGERY RESTELLA; SURGICAL MESH

Catalog Number	R20153-2020G
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	11/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient with an approximately 10-year old subpectoral breast reconstruction underwent a bilateral subpectoral to prepectoral conversion on (b)(6) 2019.The implants were anteriorly covered with restella resorbable (pga).The patient returned on (b)(6) 2019 (55 days post op) with breakdown of the 10-year old incision above the nipple of the left breast.As a precaution, the surgeon removed both breast implants and any unincorporated portions of the restella resorbable.
Event or Problem Description
See initial mdr report.
Additional Manufacturer Narrative
The patient's age was corrected to 51 years.The date of birth as listed in the original mdr report is correct.

• 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: 9413523
• Report Number: 3010513348-2019-00009
• Device Sequence Number: 2966973
• Product Code: FTM
• UDI-Device Identifier: 09421905067034
• UDI-Public: 09421905067034
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2019
• Report Date (Section F): 11/14/2019

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: R20153-2020G
• Device Lot Number: ERT-9E02
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/06/2019
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 12/05/2019
• 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: 51 YR