MAUDE Adverse Event Report: OVITEX REINFORCED TISSUE MATRIX; SURGICAL MESH

Model Number	F10246-1822P
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	08/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The hernia recurrence was noted at the patient's final follow-up visit (approximately 26 months post-op) in a post-market study.The patient was known to have diabetes and undergone at least one previous hernia repair, known risk factors for hernia recurrence.
Event or Problem Description
A patient enrolled in a post-market study was reported to have a hernia recurrence approximately 26 months after incisional/ventral hernia repair with ovitex 1sp.

• Brand Name: OVITEX REINFORCED TISSUE MATRIX
• Common Device Name: SURGICAL MESH
• MDR Report Key: 12750743
• Report Number: 3010513348-2021-00006
• Device Sequence Number: 17319412
• Product Code: FTM
• UDI-Device Identifier: 09421904065123
• UDI-Public: 09421904065123
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2021
• Report Date (Section F): 11/04/2021

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: 02/29/2020
• Device Model Number: F10246-1822P
• Device Catalogue Number: F10246-1822P
• Device Lot Number: ERT-8C13
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/05/2021
• Device Age: 28 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Weight: 82
• Date Report Sent to FDA: 11/04/2021