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

Catalog Number 0010212

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Seroma (2069); Reaction (2414)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

As reported, it is alleged that about 10 months post implant of the bard/davol ventrio mesh, the patient had a reaction to the ptfe component, fluid collection positive for bacteria.It was also reported that the patient had subsequent surgical intervention for removal of the ptfe component.Due to privacy laws in (b)(6), contact information was not provided, as such we are unable to request additional information.Based on the limited information provided, we are unable to determine to what extent, the bard device may be causing or contributing to the reported postoperative symptoms.No lot number has been provided; therefore, a review of the manufacturing records is not possible.The instructions-for-use (ifu) supplied with the device lists seroma, infection and allergic reaction as possible complications.In regards to the infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection may require removal of the prosthesis." should additional information be provided, a supplemental mdr will be submitted.

Event Description

The following was reported via tga report (australia fda): "device impacted (implanted) (b)(6) 2019, and explanted (b)(6) 2020.Body reacted to white plastic coating on mesh - ptfe.Continuous build up of fluid if¿s with multiple sinus opening to allow the fluid to escape.The ptfe coating was removed in (b)(6) 2020.At this time the ptfe component was removed from the bard ventrio mesh 13.8 x 17.8 cm.Wound drain fluid stain positive for a modified zen strain, possibly nocardia.But, no bacteria actually grown on culture.".

• 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: 10919440
• MDR Text Key: 218680819
• Report Number: 1213643-2020-20061
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016394
• UDI-Public: (01)00801741016394
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0010212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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