MAUDE Adverse Event Report: AROA BIOSURGERY LTD. 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
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 device met the tested specification.
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.
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 device met the tested specification.Note: submission of this report through esg was delayed due to ongoing issues with access to the webtrader application.Multiple tickets lodged with the esg help desk are on file at aroa biosurgery.

• Brand Name: OVITEX REINFORCED TISSUE MATRIX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY LTD.; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• Manufacturer (Section G): AROA BIOSURGERY LTD.; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• Manufacturer Contact: tina o'brien ; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• MDR Report Key: 16143272
• Report Number: 3007321028-2022-00055
• Device Sequence Number: 6736526
• Product Code: FTM
• UDI-Device Identifier: 09421904065093
• UDI-Public: 09421904065093
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K153632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IODOFORM GAUZE; IODOFORM GAUZE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 88 KG