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

Catalog Number 0010217

Device Problems Material Separation (1562); Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, no conclusion can be made.As reported, approximately 10 years post-implant of the ventrio mesh, the patient experienced abdominal abscess and infection, and underwent surgical intervention with partial explant of the mesh.The surgeon notes that the mesh had ¿started separating.¿ review of manufacturing records indicate product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in may, 2011.Regarding infection the warnings section of instructions for use (ifu) supplied with this device 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." note the reported date of implant is prior to the release of the reported product code/lot number for distribution.If/when additional information is received a supplemental mdr will be submitted.Not returned.

Event Description

On (b)(6) 2011- the patient underwent incisional hernia repair with implant of a bard/davol x-large ventrio mesh.In (b)(6) 2021 - the patient returned two weeks before (b)(6) 2021 with an abdominal abscess.On (b)(6) 2021 - the surgeon performed an exploratory laparotomy and discovered that the mesh had separated from the layers.As reported, "the surgeon stated that the mesh had started separating and he thinks this caused an infection." as reported, the surgeon felt that mesh was possibly defective and should not have separated.The remnant of the mesh was sent to pathology.As reported, the patient is doing well and was discharged to home.

• Brand Name: VENTRIO MESH
• Type of Device: 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: 11966894
• MDR Text Key: 255134578
• Report Number: 1213643-2021-20142
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016448
• UDI-Public: (01)00801741016448
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2014
• Device Catalogue Number: 0010217
• Device Lot Number: HUVE0919
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention