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

Model Number F10244-1218L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hernia (2240)

Event Date 02/26/2024

Event Type  Injury  

Event Description

It was reported that a patient experienced a hernia recurrence approximately 14 months after ventral/incisional hernia repair.The patient underwent reoperation to repair the hernia recurrence and to remove the originally implanted device.

• Brand Name: OVITEX REINFORCED TISSUE MATRIX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): TELA BIO; 1 great valley parkway; suite 24; malvern PA 19355
• MDR Report Key: 18924819
• MDR Text Key: 337916099
• Report Number: 3010513348-2024-00007
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 09421904065796
• UDI-Public: 09421904065796
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: F10244-1218L
• Device Catalogue Number: F10244-1218L
• Device Lot Number: ERT-22C28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2024
• Distributor Facility Aware Date: 02/27/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 124 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White