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

Catalog Number 0010301

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Hernia (2240)

Event Date 12/21/2009

Event Type  Injury  

Manufacturer Narrative

There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient. Based on the limited information provided at this time, no conclusions can be made. As reported it appears the patient experienced multiple internal herniations. Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication. Should additional information be obtained, a supplemental emdr will be submitted. Not returned.

Event Description

It was reported that on (b)(6) 2005 the patient was implanted with a bard/davol ventralex hernia patch for the repair of a ventral hernia. As reported the patient had complaints of pain following the implant and was diagnosed with a recurrent hernia. It is alleged that on (b)(6) 2009 the patient underwent a laparoscopic repair of a recurrent ventral hernia. Per the contact, the operative dictation indicates there were 3 hernias. One being at the incisional site of the previous repair, one being just below the umbilicus and one smaller hernia in the ventral abdomen. As reported there is no indication the bard/davol ventralex hernia patch was explanted at this time. As reported dual sided "prolene" (non bard/davol) mesh was implanted to repair the umbilical hernia.

• Brand Name: MESH - VENTRALEX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 7152723
• MDR Text Key: 96005098
• Report Number: 1213643-2017-01127
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K024008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/28/2010
• Device Catalogue Number: 0010301
• Device Lot Number: 43FPD441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/28/2017 Patient Sequence Number: 1