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

Catalog Number 0010302

Device Problems Defective Device (2588); Folded (2630)

Patient Problems Adhesion(s) (1695); Fistula (1862); Pain (1994)

Event Date 01/08/2015

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 the patient's attorney has not provided medical records.Without a lot number a review of the manufacturing records could not be conducted.It is alleged the patient experienced fistula and adhesions.Both fistula and adhesions are listed as possible known adverse reactions in the instructions-for-use.With the currently available information, no conclusion can be drawn.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.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 to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2006 - patient underwent surgery for repair of an incarcerated umbilical hernia.A ventralex mesh was implanted to repair the hernia defect.On (b)(6) 2015 - patient underwent exploratory laparotomy after presenting to the er 5 days prior with complaints of abdominal pain.Upon examination, the surgeon noted that the outer flange of the ventralex mesh had flipped inward, causing small bowel adhesions and this fistula formation and abdominal wall abscess.The surgeons removed the mesh and consequently approximately 10cm of small bowel, and then performed a resection to repair the damaged area.Patient remained in the hospital for approximately two weeks post op.The attorney alleges the patient experienced pain, adhesions, fistula, abscess, explant and permanent injury.

• Brand Name: 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: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 6247769
• MDR Text Key: 64712510
• Report Number: 1213643-2017-00024
• 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: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0010302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2016
• 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): Hospitalization; Required Intervention; Disability