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

Catalog Number	0010217
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	08/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, post implant of ventrio hernia patch, the patient was diagnosed with a seroma, which resolved with no treatment required.The clinician has assessed the patient¿s postoperative course as being possibly related to the study device and definitely related to the index procedure, however, based on the information provided, no conclusions can be made.Seroma formation is a known inherent risk of the surgery and included as a possible complication in the adverse reactions section of the instructions for use supplied with the device.To date, this is the only reported complaint for this manufacturing lot.Device not returned - remains implanted.
Event or Problem Description
Reported per clinical trial dvl-he-020: (b)(6) 2017 subject patient underwent primary open ventral left subcostal hernia repair.The size of the hernia defect was 26 cm x 10 cm.A bard/davol ventrio hernia patch was placed in an underlay fashion fixated using mechanical fixation device and suture.Fascia closure was completed using mechanical suture and full skin closure was achieved using staples.The patient was discharged to home on (b)(6) 2017.(b)(6) 2017 subject patient was diagnosed with seroma.This ae is clinically assessed to be possibly related to the study device and definitely related to the procedure.This has been assessed as a non-serious adverse event of mild severity and has resolved.No action taken.The reported adverse events does not meet the definition of an sae (serious adverse event).

• 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: 14457271
• Report Number: 1213643-2022-00256
• Device Sequence Number: 4570258
• Product Code: FTL
• UDI-Device Identifier: 00801741016448
• UDI-Public: (01)00801741016448
• 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: 2017
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2019
• Device Catalogue Number: 0010217
• Device Lot Number: HUAP2119
• 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: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 77 KG