MAUDE Adverse Event Report: AROA BIOSURGERY OVITEX LPR; SURGICAL MESH

Model Number	F10244-1218L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Seroma (2069)
Date of Event	11/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The surgeon noted that the patient had both latex and seasonal allergies.
Event or Problem Description
It was reported that a patient complained of post operative pain after ventral/incisional hernia repair with ovitex lpr.After medication did not resolve the issue, an exploratory operation was performed.Upon reoperation, fluid collection was noted; further, adhesions were noted that were easily freed with blunt dissection.The device was removed and replaced with an alternative reinforcement material.

• Brand Name: OVITEX LPR
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• MDR Report Key: 18384533
• Report Number: 3010513348-2023-00014
• Device Sequence Number: 2759557
• Product Code: FTM
• UDI-Device Identifier: 09421904065796
• UDI-Public: 09421904065796
• 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: 2023
• 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): 12/22/2023
• Report Date (Section F): 12/22/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: F10244-1218L
• Device Catalogue Number: F10244-1218L
• Device Lot Number: ERT-21L01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/29/2023
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2023
• 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: 42 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/22/2023