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

Catalog Number	F10248-1620P
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	09/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient who underwent a bridging hernia repair with ovitex 2sp on (b)(6) 2019 presented with a seroma approximately two weeks after surgery.It is reported that the patient was re-admitted to the or and that the surgeon found that the implant had been partially resorbed or digested and that the synthetic portion remained behind.The remaining portions were explanted.

• 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: 9181893
• Report Number: 3010513348-2019-00005
• Device Sequence Number: 3642690
• Product Code: FTM
• UDI-Device Identifier: 09421904065185
• UDI-Public: 09421904065185
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2019
• Report Date (Section F): 10/11/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: F10248-1620P
• Device Lot Number: ERT-8B03
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/16/2019
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2019
• 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: Hospitalization; Required Intervention
• Date Report Sent to FDA: 10/11/2019