MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX; SURGICAL MESH

Catalog Number 0115321

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Dysuria (2684); Constipation (3274)

Event Date 06/12/2018

Event Type  Injury  

Manufacturer Narrative

As reported, the patient experienced difficulty in passing urine, constipation and pain in the bowel area post 3dmax mesh implant.The implanting surgeon does not believe the patient's symptoms to be associated with hernia repair surgery.The patient has been diagnosed by a urologist with chronic pelvic pain syndrome.Based on the information provided, no conclusion can be made as to the degree to which the implanted mesh, may be causing or contributing the patient¿s reported symptoms.To date, this is the only reported complaint for this manufacturing lot.Review of manufacturing records indicate product was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in may, 2017.This emdr represents the bard/davol 3dmax mesh (device #2).An additional emdr was submitted to represent the bard/davol 3dmax mesh (device #1).Should additional information be provided, a supplemental emdr will be submitted.Not returned - remains implanted.

Event Description

As reported per the surgeon: on (b)(6) 2018 - the patient was implanted with two 3dmax meshes bilaterally (right and left side) in a laparoscopic inguinal hernia repair procedure.On (b)(6) 2018 - the patient was discharged.After surgery, the patient had complaints of difficulty in passing urine and constipation.The surgeon informed that the problems were not related to the mesh.On (b)(6) 2018 - the patient had follow-up visits due to pain in the bowel area near mesh implant, discomfort in lower abdomen and incomplete sense of evacuation.As reported, the patient has consulted with urologists and has been diagnosed with chronic pelvic pain syndrome (cpps) with no relation to the lap procedure.The patient is doing well with no medical or surgical intervention required.

• Brand Name: 3DMAX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 11253211
• MDR Text Key: 229474914
• Report Number: 1213643-2021-20014
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030765
• UDI-Public: (01)00801741030765
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K081010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2021

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: 04/28/2022
• Device Catalogue Number: 0115321
• Device Lot Number: HUBR1474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2021
• Initial Date FDA Received: 01/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2017
• 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