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

Model Number 5950007

Device Problems Defective Device (2588); Insufficient Information (3190)

Patient Problems Pain (1994); Hernia (2240); Disability (2371)

Event Date 03/15/2017

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event. The information provided alleges that the, "patient underwent an additional surgery to repair the hernia defect and remove it. " as medical records were not provided and the description does not clearly define what "remove it" is referring to (example possible mesh explant, partial explant, or removal/repair of the hernia defect itself without explant of previously placed mesh). As such, we have not identified this as reported device explant at this time. It is unclear at this time if the hernia defect repaired post implant of the mesh was a recurrence of the original hernia defect or a new hernia defect. However, 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. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. Not returned.

Event Description

It is alleged by the patients attorney that on (b)(6) 2013, the patient underwent surgery for repair of an umbilical hernia. As reported, a bard/davol ventralex hernia patch mesh, (b)(4), lot number huxe0717 was implanted to repair the hernia defect. It is alleged that several years later on (b)(6) 2017, the patient underwent an additional surgery to repair the hernia defect and "remove it. " as alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective ventralex st hernia patch is defective.

• Brand Name: VENTRALEX ST
• 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: jessica messier ; 100 crossings blvd.; warwick, RI 02886 ; 4018258720
• MDR Report Key: 7142870
• MDR Text Key: 95646919
• Report Number: 1213643-2017-01102
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/28/2015
• Device Model Number: 5950007
• Device Catalogue Number: 5950007
• Device Lot Number: HUXE0717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2013
• 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: 12/22/2017 Patient Sequence Number: 1