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

Model Number	F10256-2020G
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hernia (2240)
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient located outside of the united states underwent repair of an external pelvic organ prolapse with ovitex r.The patient experienced a recurrence of this external prolapse.This is one of two reports from the same investigator initiated study.

• 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: 13170992
• Report Number: 3010513348-2022-00002
• Device Sequence Number: 11917090
• Product Code: FTM
• UDI-Device Identifier: 09421904065345
• UDI-Public: 09421904065345
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/05/2022
• Report Date (Section F): 01/05/2021

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: 11/30/2021
• Device Model Number: F10256-2020G
• Device Catalogue Number: F10256-2020G
• Device Lot Number: ERT-20F07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2022
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/05/2021