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

Model Number F10256-2020G

Device Problem Insufficient Information (3190)

Patient Problem Hernia (2240)

Event Type  Injury  

Event 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
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• MDR Report Key: 13170992
• MDR Text Key: 285075432
• Report Number: 3010513348-2022-00002
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 09421904065345
• UDI-Public: 09421904065345
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2021,01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Report Sent to FDA: 01/05/2021
• Distributor Facility Aware Date: 12/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention