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

Model Number	F10244-1020P
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a potential "reaction" to an ovitex p mesh implanted on (b)(6) 2019.It was removed on (b)(6) 2020.

• 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: 10189578
• Report Number: 3010513348-2020-00004
• Device Sequence Number: 908592
• Product Code: FTM
• UDI-Device Identifier: 09421904065031
• UDI-Public: 09421904065031
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2020
• Report Date (Section F): 06/24/2020

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: 05/31/2020
• Device Model Number: F10244-1020P
• Device Catalogue Number: F10244-1020P
• Device Lot Number: ERT-8F03
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/05/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2020
• 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
• Patient Age: 48 YR
• Patient Weight: 60
• Date Report Sent to FDA: 06/24/2020