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

Model Number	F10248-1020P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intraperitoneal placement of surgical mesh carries a known risk of adhesions.Such adhesions, whether device or surgery related, may lead to small bowel obstruction.It cannot be definitively determined whether the device contributed to this event.
Event or Problem Description
A small bowel obstruction was reported after the use of ovitex 2s permanent in open ipom sugarbaker parastomal hernia repair.This required reoperation at which time there were noted loops of small bowel attached to the device and to the colon on the opposite side.The surgeon took down adhesions and corrected tears as necessary.

• 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: 15266190
• Report Number: 3010513348-2022-00005
• Device Sequence Number: 20280413
• Product Code: FTM
• UDI-Device Identifier: 09421904065178
• UDI-Public: 09421904065178
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 08/22/2022
• Report Date (Section F): 08/22/2022

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: F10248-1020P
• Device Catalogue Number: F10248-1020P
• Device Lot Number: ERT-21F12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2022
• 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: Male
• Date Report Sent to FDA: 08/22/2022