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

Model Number	F10256-2020G
Medical Device Problem Codes	Off-Label Use (1494); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hernia (2240)
Type of Reportable Event	Serious Injury
Additional 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 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.
Additional 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 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 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
• Report Number: 3007321028-2022-02621
• Device Sequence Number: 4653646
• Product Code: FTM
• UDI-Device Identifier: 09421904065345
• UDI-Public: 09421904065345
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K130547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2022

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown