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

Catalog Number 0010301

Device Problems Detachment of Device or Device Component (2907); Extrusion (2934)

Patient Problems Unspecified Infection (1930); Pain (1994); Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records was performed and found that the lot was manufactured to specification. Recurrence and extrusion are listed in the adverse reaction section of the ifu as possible complications. Regarding infection the warning section of the ifu states, "if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. An unresolved infection, however, may require removal of the prosthesis. The patient stated that he does not wish to be contacted and did not provide contact information. Therefore, we are unable to request any additional information. Based on the limited information provided, no conclusion can be made. Should the patient contact davol with additional information, a supplemental mdr will be submitted. A separate mdr was submitted to document the other bard ventralex hernia patch reported to have been implanted in 2012. 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. Remains implanted.

Event Description

The patient has reported to davol that in 2012 he was implanted with two ventralex hernia patches for hernia repair. Following implant the patient reports that he developed an infection and that pieces of mesh were sticking through the wound. These pieces were removed. He reports that he has recently developed another hernia and that he is experiencing worsening pain and is unable to go to the bathroom. He reports his doctor ¿looked inside of him with a camera and said the mesh is loose and is the source of the pain. ".

• 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 berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6131665
• MDR Text Key: 61019362
• Report Number: 1213643-2016-00541
• 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: Patient
• Type of Report: Initial
• Report Date: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 0010301
• Device Lot Number: HUVI0021
• 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: 11/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• 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: 11/29/2016 Patient Sequence Number: 1