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

Model Number F10246-1620P

Device Problem Insufficient Information (3190)

Patient Problem Abdominal Pain (1685)

Event Date 01/15/2020

Event Type  Injury  

Event Description

A patient presented with pain and discomfort after laparoscopic repair of a hernia.Upon reoperation, the surgeon found the device unincorporated and he removed the device.

• Brand Name: OVITEX REINFORCED BIOSCAFFOLD
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsford smith place; airport oaks; auckland, 2022 ; NZ 2022
• MDR Report Key: 9667744
• MDR Text Key: 179813391
• Report Number: 3010513348-2020-00002
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 09421904065048
• UDI-Public: 09421904065048
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: F10246-1620P
• Device Catalogue Number: F10246-1620P
• Device Lot Number: ERT-8L10
• 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: 02/04/2020
• Distributor Facility Aware Date: 01/15/2020
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2020
• 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