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

Model Number F10246-1620P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Seroma (2069)

Event Date 10/02/2020

Event Type  Injury  

Manufacturer Narrative

Review of manufacturing records did not result in any indication of a device problem.

Event Description

A patient underwent ventral hernia repair with ovitex 1sp on (b)(6) 2018.The patient developed persistent infection and wound dehiscence with presence of seroma.Surgical intervention was conducted on (b)(6) 2020 including debridement of abdominal wall skin/sinus tract and removal of embedded repair material.

• 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 o'brien ; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• MDR Report Key: 12595175
• MDR Text Key: 278759100
• Report Number: 3007321028-2021-00013
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 09421904065116
• UDI-Public: 09421904065116
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2018
• Device Model Number: F10246-1620P
• Device Catalogue Number: F10246-1620P
• Device Lot Number: ERT-6I10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2016
• 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
• Patient Age: 73 YR
• Patient Weight: 81