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

Catalog Number UNKAA077

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

Patient Problems Fistula (1862); Neuropathy (1983); Disability (2371)

Event Date 06/15/2015

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.To date no medical records have been provided.As alleged by the patient's attorney the patient had a fistula; fistulas are a known risk of surgery and are listed as a possible complication in the instructions-for-use.The patient's attorney did not allege any specific device failure and a sample was not returned for further evaluation.No lot number was provided; therefore a review of the manufacturing records is not possible at this time.Based on the limited information provided by the patient's attorney, no conclusions can be made between the bard/davol device used to treat the patient and any problem with the device.Should additional information be provided, a supplemental emdr will be submitted.Note: the actual date of removal surgery (device 1) / implant surgery (device 2) is unknown, therefore we are using 6/15/2015 as a date of explant of (device 1) and implant of the ventralex (device 2).This emdr represents the bard/davol ventralex (device 1); an additional emdr will be submitted to represent the bard/davol ventralex (device 2).Note: the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Not returned.

Event Description

The following was alleged by the patient's attorney: on (b)(6) 2011 - the patient was implanted with bard/davol ventralex mesh (device 1) for the repair of an umbilical hernia.On ni/ni/2015 - the patient underwent removal surgery.Upon entering the abdominal cavity, the patient's surgeon noted that the bard ventralex mesh (device 1) had failed and removed the mesh, during this surgery, the surgeon implanted another bard/davol ventralex mesh (device 2) for a ventral hernia.As reported, the patient has suffered pain, neuropathy, fistula, scarring, and intestinal blockage and will continue to suffer physical pain from her hernia mesh surgery.(devices 1 and 2).The patient's attorney alleges "as a result of having the bard ventralex mesh (devices 1 and 2) implanted, the patient has experienced significant physical pain and suffering, has sustained permanent injury, and has undergone medical treatment and will likely undergo further medical treatment and procedures.".

• 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 abrams ; 100 crossings blvd.; warwick, RI 02886 ; 4018258605
• MDR Report Key: 7610413
• MDR Text Key: 111360705
• Report Number: 1213643-2018-02009
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021736
• 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: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2018
• 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; Disability