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	Seroma (2069)
Date of Event	02/05/2014
Type of Reportable Event	Malfunction
Event or Problem Description
Reported per clinical trial dvl-he-020: (b)(6) 2014 subject patient underwent primary open midline umbilical hernia repair procedure.A bard/davol ventrio hernia patch was placed intra-peritoneal in an underlay technique.Non-bard/davol mechanical fixation and sutures were used.Full skin closure was achieved using sutures and adhesive skin closure.The patient was discharged to home on (b)(6) 2014.(b)(6) 2014 subject patient was diagnosed with subcutaneous seroma; no action taken.(b)(6) 2014 reported end date for the adverse event.Per the study clinician, the reported adverse event has been assessed as moderate in severity, possibly related to the study device and possibly related to the index procedure.As reported, the ae is reported as recovered/resolved.
Additional Manufacturer Narrative
As reported, about one week post-implant of ventrio mesh, 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 possibly related to the index procedure, however, based on the information provided, no conclusion can be made.Seroma is a known inherent risk of hernia repair surgery.The instructions-for-use, supplied with the device lists seroma as a possible complication.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 189 units released for distribution in (b)(6) 2013.Device 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: 14488616
• Report Number: 1213643-2022-00304
• Device Sequence Number: 5322793
• 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: 2014
• 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: 05/28/2016
• Device Catalogue Number: 0010215
• Device Lot Number: HUXE0351
• 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: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2013
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 66 KG