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

Model Number F10256-2020G

Device Problems Off-Label Use (1494); Insufficient Information (3190)

Patient Problem Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

Ovitex devices are not indicated for pelvic organ prolapse procedures, thus the device was used in an off-label manner.No device problem was found from review of the dhr.The devices in ert-20f07 were produced as per established manufacturing procedures.All process specifications including package labelling requirements were met.

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.

Manufacturer Narrative

Ovitex devices are not indicated for pelvic organ prolapse procedures, thus the device was used in an off-label manner.No device problem was found from review of the dhr.The devices in ert-20f07 were produced as per established manufacturing procedures.All process specifications including package labelling requirements were met.

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 LTD.; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• Manufacturer (Section G): AROA BIOSURGERY LTD.; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• Manufacturer Contact: tina obrien ; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• MDR Report Key: 13178939
• MDR Text Key: 285924598
• Report Number: 3007321028-2022-02621
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 09421904065345
• UDI-Public: 09421904065345
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K130547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• 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
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention