MAUDE Adverse Event Report: AROA BIOSURGERY OVITEX REINFORCED TISSUE MATRIX; SURGICAL MESH

Model Number	F10254-2020G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a persistent seroma after implantation of ovitex r to reinforce a diep flap donor site on (b)(6) 2021.The implanted material was partially removed on (b)(6) 2021.

• Brand Name: OVITEX REINFORCED TISSUE MATRIX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• MDR Report Key: 13001805
• Report Number: 3010513348-2021-00007
• Device Sequence Number: 4316338
• Product Code: FTM
• UDI-Device Identifier: 09421904065277
• UDI-Public: 09421904065277
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/14/2021
• Report Date (Section F): 12/14/2021

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: 06/30/2022
• Device Model Number: F10254-2020G
• Device Catalogue Number: F10254-2020G
• Device Lot Number: ERT-21A02
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/29/2021
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/14/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 43 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/14/2021