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

Catalog Number	F10248-2540P
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Seroma (2069)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsford smith place; airport oaks; auckland, 2022 ; NZ 2022
• MDR Report Key: 8880129
• Report Number: 3010513348-2019-00001
• Device Sequence Number: 14004764
• Product Code: FTM
• UDI-Device Identifier: 09421904065758
• UDI-Public: 09421904065758
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2019
• Report Date (Section F): 07/17/2019

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 Expiration Date: 07/31/2020
• Device Catalogue Number: F10248-2540P
• Device Lot Number: ERT-8H09
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/15/2019
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2019
• 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: Required Intervention