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

Model Number F10246-2020P

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

Patient Problems Abscess (1690); Fistula (1862)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

It is likely that the fistula formed secondary to a surgical error in the initial procedure such as a small bowl perforation.This would lead to fistula formation, abscess, and gross inflammation accounting for the noted extensive adhesions.Given the short time frame between initial surgery and the events noted (approximately 1 month), it is highly unlikely that the device would have caused or contributed to these events.While it is unlikely that the device is the initiating cause of the abscess and fistula, its presence may have been a factor in the inflammatory response and subsequent removal.

Event Description

After ventral hernia repair with ovitex 1sp on (b)(6) 2019, a patient presented with general malaise and fever.She presented with an abdominal wall abscess and small bowel fistula on (b)(6) 2019 with surgery to resolve.A portion of the device was removed.Part of the device was adherent to the small bowel and remained in situ.

• Brand Name: OVITEX REINFORCED TISSUE MATRIX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsford smith place; airport oaks; auckland, 2022 ; NZ 2022
• MDR Report Key: 12533783
• MDR Text Key: 273371829
• Report Number: 3010513348-2021-00005
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 09421904065130
• UDI-Public: 09421904065130
• 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: 09/27/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: F10246-2020P
• Device Catalogue Number: F10246-2020P
• Device Lot Number: ERT-7J01
• 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: 09/27/2021
• Distributor Facility Aware Date: 03/25/2019
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 84