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

Model Number	F10246-2020P
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Adhesions are a common event after abdominal surgery and may lead to complicatoins resulting in surgical intervention.A partial resorption of the biologic material without concurrent tissue remodeling may have contributed to this event.Such resorption may be a result of patient conditions or adverse events such as infection or seroma.It is unknown in this case whether underlying factors or comorbidities caused or contributed to this event.
Event or Problem Description
A patient underwent hernia repair with ovitex 1sp on (b)(6) 2022.The repair was robotically completed (ipom) with fascial closure.The patient returned in late (b)(6) 2023 complaining of pain with ct scan confirming a hernia recurrence.Surgery was conducted on (b)(6) 2023 to address the recurrence at which point bowel adhesions were noted.The surgeon performed adhesiolysis to separate bowel from the remaining device.Hernia reduction was achieved and the hernia repaired.

• 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: 16952205
• Report Number: 3010513348-2023-00004
• Device Sequence Number: 11598040
• Product Code: FTM
• UDI-Device Identifier: 09421904065130
• UDI-Public: 09421904065130
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2023
• Report Date (Section F): 05/18/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: F10246-2020P
• Device Catalogue Number: F10246-2020P
• Device Lot Number: ERT-21A13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/28/2023
• Device Age: 15 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2023
• 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: 56 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/18/2023