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

Model Number	F10246-1012P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Seroma (2069)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient with perforated diverticulitis post colostomy underwent robotic lysis of adhesions, partial colectomy and low colorectal anastomosis to take down the colostomy.The surgeon then made an exterior incision at site of the colostomy to close the defect.The surgeon placed ovitex in an onlay fashion over the closed defect.During post-surgical follow up the patient experienced an abscess and persistent seroma which has been drained multiple times under interventional radiology.
Additional Manufacturer Narrative
A review of the batch record showed no nonconformances or other anomalies that may have caused or contributed to the event reported.Testing was completed on similar units which showed the devices met the tested specification.

• 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: 16055550
• Report Number: 3010513348-2022-00011
• Device Sequence Number: 20392856
• Product Code: FTM
• UDI-Device Identifier: 09421904065093
• UDI-Public: 09421904065093
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2022
• Report Date (Section F): 12/27/2022

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: 10/31/2024
• Device Model Number: F10246-1012P
• Device Catalogue Number: F10246-1012P
• Device Lot Number: ERT-21K06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/29/2022
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IODOFORM GAUZE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Date Report Sent to FDA: 12/27/2022