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

Catalog Number 5950008

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

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

Event Date 09/15/2016

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the bard/davol ventralex st device may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges the patient underwent removal surgery in 2016 and has allegedly "suffered pain, neuropathy, fistula, scarring, and intestinal blockage".No medical records have been provided; however, fistula formation is identified in the adverse reaction section of the instructions-for-use as a possible complication.Based on the limited information provided at this time, no conclusions can be made.The actual date of implant is unknown, reported as "2016"; therefore, we are using (b)(6) 2016 as implant date.Likewise, the date of explant is unknown, also reported as "2016"; therefore, we are using (b)(6) 2016 as date of explant.Should additional information be provided a supplemental emdr will be submitted.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: in 2016, the patient was implanted with a bard/davol ventralex st mesh, reference number (b)(4), lot huzi1883, for the repair of an inguinal hernia.As reported, in 2016 that the patient underwent removal surgery.It is alleged that, the patient's surgeon noted that the bard/davol ventralex st mesh had failed and removed part of the mesh.It is alleged that the patient has suffered pain, neuropathy, fistula, scarring, and intestinal blockage and will continue to suffer physical pain from his hernia mesh surgery.

• 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: francesca santamaria ; 100 crossings blvd.; warwick, RI 02886 ; 4018258538
• MDR Report Key: 7613078
• MDR Text Key: 111440244
• Report Number: 1213643-2018-02029
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031489
• UDI-Public: (01)00801741031489
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101851
• 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: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2017
• Device Catalogue Number: 5950008
• Device Lot Number: HUZI1883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2015
• 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