MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRIO MESH; SURGICAL MESH

Catalog Number	0010212
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Bacterial Infection (1735); Seroma (2069)
Date of Event	12/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported per clinical trial (b)(4): (b)(6) 2019 - subject patient underwent first time recurrent open midline incisional hernia (6x1 cm) repair procedure during which a bard/davol ventrio hernia patch was implanted.Fascia and full skin closure was achieved with non-bard/davol maxon suture and staples.(b)(6) 2019 - subject patient was diagnosed with an infected wound seroma.(b)(6) 2019 - subject patient was admitted for superficial surgical site infection (ssi).(b)(6) 2019 - subject patient underwent incision and drainage of the wound seroma at the infection site with a liter of saline and betadine.Culture was positive for staphylococcus aureus.The patient was hospitalized until (b)(6) 2019.Per the study clinician, the reported adverse event has been assessed as severe in severity, possibly related to study device and definitely related to the index procedure.The outcome for this ae is reported as resolved.
Additional Manufacturer Narrative
As reported, about three weeks post-implant of the bard/davol ventrio mesh, the patient was diagnosed with infected wound seroma and underwent incision & drainage.As reported, the ae is resolved.The clinician has assessed the patient¿s postoperative course as being "possibly" related to the study device and definitely related to the procedure, however, based on the information provided, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.Seroma formation is a known inherent risk of hernia repair surgery.The adverse reactions section of the instructions-for-use supplied with the device lists seroma as a possible complication.In regards to the infection, the warnings section of the instructions-for-use (ifu) states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." remains implanted.

• Brand Name: VENTRIO MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 14465052
• Report Number: 1213643-2022-00267
• Device Sequence Number: 19976041
• Product Code: FTL
• UDI-Device Identifier: 00801741016394
• UDI-Public: (01)00801741016394
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2022

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: 11/28/2021
• Device Catalogue Number: 0010212
• Device Lot Number: HUCP2089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 110 KG