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

Model Number	F10244-0909L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Adhesion(s) (1695)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Adhesions are a common event after surgery with or without the use of surgical mesh.It is unknown whether the device caused or contributed to the need for reoperation in this case.
Event or Problem Description
An ovitex lpr device was used to reinforce and repair the abdominal wall after prostatectomy in the ingunal space.It was reported that the patient experienced symptoms of a small bowel obstructions and underwent a secondary surgery where adhesions to the device were found and were taken down.

• 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: 13266628
• Report Number: 3010513348-2022-00003
• Device Sequence Number: 19212065
• Product Code: FTM
• UDI-Device Identifier: 09421904065765
• UDI-Public: 09421904065765
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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): 01/17/2022
• Report Date (Section F): 01/17/2022

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 Model Number: F10244-0909L
• Device Catalogue Number: F10244-0909L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2022
• 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: 01/17/2022