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

Model Number F10248-2540P

Device Problem Insufficient Information (3190)

Patient Problem Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

A dhr review was completed and no non-conformances or anomalies were found that may have caused or contributed to this event.As of the week of (b)(6) 2019 it has been reported that the patient has improved, though no clinical details were shared.Therefore, it is unknown whether the device caused or contributed to this event.

Event Description

Ovitex 2sp was used to repair a ventral hernia via a bridging repair in (b)(6) 2018.It was reported that after this repair that the wound and hernia have healed, but the patient developed persistent superficial drainage.The patient has been managed for approximately eight months post-op.

• Brand Name: OVITEX REINFORCED BIOSCAFFOLD
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY LTD.; 2 kingsford smith place; airport oaks, 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: 8876750
• MDR Text Key: 153813878
• Report Number: 3007321028-2019-00007
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 09421904065758
• UDI-Public: 09421904065758
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: F10248-2540P
• Device Catalogue Number: F10244-2530P
• Device Lot Number: ERT-8H09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2018
• 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): Required Intervention