MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3DMAX; SURGICAL MESH

Catalog Number UNKAA001

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

Patient Problems Fistula (1862); Neuropathy (1983); Hernia (2240)

Event Date 06/15/2017

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made to what extent the bard/davol 3dmax (device #1)may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.Recurrence and fistulas is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/ davol 3dmax (device #1).The patient's attorney did not make any allegations regarding the implanted bard/ventralex.Note: not returned.

Event Description

The following was alleged by the patient's attorney: (b)(6) 2016: the patient was implanted with a bard/davol 3dmax (device #1) for the repair of an inguinal hernia.The patient underwent removal surgery in 2017 and upon entering the abdominal cavity, the patients' surgeon noted that the bard/davol 3dmax (device #1) had failed and removed the mesh.At the same time as the 3dmax (device #1) was removed, the surgeon implanted a bard/davol ventralex mesh in an attempt to repair the recurring inguinal hernia that was aggravated and caused by the initial mesh repair surgery.It is alleged that the patient has experienced abdominal pain, bloating and was/is limited in his mobility due to his injuries from the bard/davol 3dmax (device #1).The patient has suffered pain, neuropathy, fistula, scarring and intestinal blockage and will continue to suffer physical pain and mental anguish from his hernia mesh injury.As a result of having the bard/davol 3dmax (device #1) implanted, the patient has experienced significant physical pain and suffering, has sustained permanent injury, has undergone medical treatment and will likely undergo further medical treatment and procedures due to the alleged defective 3dmax (device #1).

• Brand Name: 3DMAX
• 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: jan ling ; 100 crossings blvd.; warwick, RI 02886 ; 8015652663
• MDR Report Key: 8180418
• MDR Text Key: 130884244
• Report Number: 1213643-2018-04875
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2018
• 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