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

Model Number	F10246-2020P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Fistula (1862)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is likely that the fistula formed secondary to a surgical error in the initial procedure such as a small bowl perforation.This would lead to fistula formation, abscess, and gross inflammation accounting for the noted extensive adhesions.Given the short time frame between initial surgery and the events noted (approximately 1 month), it is highly unlikely that the device would have caused or contributed to these events.While it is unlikely that the device is the initiating cause of the abscess and fistula, its presence may have been a factor in the inflammatory response and subsequent removal.
Event or Problem Description
After ventral hernia repair with ovitex 1sp on (b)(6) 2019, a patient presented with general malaise and fever.She presented with an abdominal wall abscess and small bowel fistula on (b)(6) 2019 with surgery to resolve.A portion of the device was removed.Part of the device was adherent to the small bowel and remained in situ.

• 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: 12533783
• Report Number: 3010513348-2021-00005
• Device Sequence Number: 1295786
• Product Code: FTM
• UDI-Device Identifier: 09421904065130
• UDI-Public: 09421904065130
• 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: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2021
• 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: 09/30/2019
• Device Model Number: F10246-2020P
• Device Catalogue Number: F10246-2020P
• Device Lot Number: ERT-7J01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/25/2019
• Device Age: 17 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: 75 YR
• Patient Weight: 84
• Date Report Sent to FDA: 09/27/2021