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

Model Number	F10246-1620P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Seroma (2069); Post Operative Wound Infection (2446)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This patient experienced a persistent infection, wound dehiscence, and related events leading to eventual device removal.As these events were first experienced superficially, is unlikely that the implanted device was the initiating cause of these events.
Event or Problem Description
A patient underwent ventral hernia repair with ovitex 1sp on (b)(6) 2018.The patient developed persistent infection and wound dehiscence with presence of seroma.Surgical intervention was conducted on (b)(6) 2020 including debridement of abdominal wall skin/sinus tract and removal of embedded repair material.

• 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: 12533761
• Report Number: 3010513348-2021-00004
• Device Sequence Number: 16467705
• Product Code: FTM
• UDI-Device Identifier: 09421904065116
• UDI-Public: 09421904065116
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2021
• Report Date (Section F): 09/27/2021

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: 08/31/2018
• Device Model Number: F10246-1620P
• Device Catalogue Number: F10246-1620P
• Device Lot Number: ERT-6I10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/09/2018
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 81
• Date Report Sent to FDA: 09/27/2021