MAUDE Adverse Event Report: AROA BIOSURGERY LTD. 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
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.
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.As the lot number information was not received, a full review of the manufacturing records was not possible.

• 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: 13266898
• Report Number: 3007321028-2022-03421
• Device Sequence Number: 1580158
• Product Code: FTM
• UDI-Device Identifier: 09421904065765
• UDI-Public: 09421904065765
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K153632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/18/2022

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown