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

Catalog Number	0010215
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	10/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported per clinical trial (b)(6): on (b)(6) 2015: subject patient underwent multiple recurrent open midline hernia (3x1 cm) repair procedure during which a bard/davol ventrio hernia patch was implanted using sutures.Fascia and full skin closure was achieved using with suture and staples.On (b)(6) 2019: subject patient was diagnosed with recurrent small midline hernia at the periumbilical region.Per the study clinician, the reported adverse event has been assessed as mild in severity, possibly related to the study device and possibly related to the index procedure.The outcome for this ae is reported as not recovered/not resolved.
Additional Manufacturer Narrative
As reported, about 4 years post-implant of the ventrio mesh, the patient diagnosed with recurrent hernia.As reported, the ae is not-resolved.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and to the procedure, however, based on the information provided, no conclusion can be made.Hernia recurrence is a known inherent risk of surgery.The instructions-for-use supplied with the device lists hernia recurrence as a possible complication.Review of manufacturing records shows product was manufactured to specification.To date, this is the only complaint reported for this manufacturing lot of (b)(4) units released for distribution in august, 2015.Device evaluated by manufacturer: not returned - 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: 14462019
• Report Number: 1213643-2022-00264
• Device Sequence Number: 11921612
• Product Code: FTL
• UDI-Device Identifier: 00801741016424
• UDI-Public: (01)00801741016424
• 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: 2015
• 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: 12/28/2018
• Device Catalogue Number: 0010215
• Device Lot Number: HUZF1041
• 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
• Date Device Manufactured: 08/04/2015
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 140 KG