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

Catalog Number 0112680

Device Problem Defective Device (2588)

Patient Problems Abdominal Pain (1685); Urinary Frequency (2275); Cancer (3262)

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including prostate cancer, chronic headaches and urinary frequency.There are no medical records provided beyond this time, therefore the patient¿s clinical course is unclear.The information provided did not mention any visualization or involvement of the bard flat mesh.No explant, pathology or diagnostic information provided.Based on the information received, there is no way to determine whether the bard flat mesh may have caused or contributed to the problems experienced due to the patient¿s medical and surgical history and the limited clinical information provided.Should additional information be provided, a supplemental emdr will be submitted.

Event Description

Per patient (pro-se): the patient was diagnosed with incarcerated right inguinal hernia on (b)(6) 1999 was implanted with bard monofilament knitted polypropylene mesh (bard flat mesh) on (b)(6)1999 to repair the hernia and mesh was sutured to pubic tubercle, inguinal ligament, transversalis, conjoined tendon and inguinal cord which were located close to patient's prostrate.It is alleged that between 2000 to this present date, the patient has suffered chronic painful and severe headaches that require continuous pain relievers.On (b)(6) 2012, the patient underwent transrectal ultrasound of prostate as well as prostate biopsy and it was discovered that the patient had stage ii chronic malignant adenocarcinoma cancer of the 'prostate with a gleason score of 3+3=6.It is alleged that on (b)(6) 2012, the surgeon discussed radiation therapy, brachytherapy and surgery to remove and stop the cancer with the patient as appropriate treatment options and their short term and long term side effects.It is also alleged that on (b)(6) 2019 the patient (psa) blood was collected and tested for psa results on (b)(6) 2019 and the test results were negatively high (with) elevation of 9.7.It is alleged that the bard mesh (bard flat mesh) and its resin material is causing the patient's psa blood levels to become negatively higher and higher by each 6-month tests beginning from 27-jul-2012 to 10-jul-2019.It is alleged that the patient suffered extremely painful headaches from (b)(6) 2000 to (b)(6) 2019; tooth loss beginning on (b)(6) 2000; stomach pains from (b)(6) 2000 to (b)(6) 2019; urinary frequency and from (b)(6) 2012 to (b)(6) 2019 and stage ii chronic adenocarcinoma prostate cancer from (b)(6) 2012 to (b)(6) 2019.As of (b)(6) 2019, the patient requested the removal of bard flat mesh and will require to undergo revision surgery to repair and remove the bard flat mesh that poses an additional risk of pain, suffering, infection, cancer, urinary frequency, dental loss, severe headaches, prostate cancer and lengthy recovery time.It is also alleged that the patient was seriously injured and sustained other physical and mental injuries due to the defective mesh.Per medical records: (b)(6) 1999 - a (b)(6) year old male patient presented to the emergency room with an incarcerated right inguinal hernia.(b)(6) 1999 - the patient underwent repair of the right inguinal hernia with implant of a bard flat mesh.Per the operative report details, ¿the inguinal canal was accessed, and the hernia sac was dissected off from the inguinal cord.A polypropylene mesh (bard flat mesh) repair was proceeded.Three interrupted 4-0 polypropylene stitches were used to secure the mesh to the pubic tubercle.Following which several more interrupted stitches were then used to secure the mesh along the shelving edge of the inguinal ligament and the transversalis and the conjoined tendon.The internal inguinal ring was then reshaped by bringing the leaves of the mesh around the inguinal cord and using a prolene stitch to secure the mesh.¿ 2010/2012 - about 13 years later, the patient had several prostate surface antigen (psa) tests performed in which the score was 2.1 in 2010 and 4.4 in (b)(6) 2012.(b)(6) 2012 - about 8 months later, the patient underwent a urologic evaluation and digital rectal exam which showed a 10 to 15g prostate without specific nodularity.(b)(6) 2012 - transrectal ultrasound demonstrated the prostate with abnormalities in the left apex, mid and base.A biopsy was then performed which showed adenocarcinoma involving the left mid and left base.Biopsies from the right anterior and left anterior were benign.(b)(6) 2012 - the patient consulted with a radiological oncologist due to the prostate cancer findings, complaints of urinary frequency and nocturia.The doctor stated that the patient had a low-risk disease, considering the prognostic factors and recommended brachytherapy, with psa testing every 3 months, rectal exams every 6 months and repeat biopsies every 12 months.

• Brand Name: BARD FLAT MESH
• 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 11083016
• MDR Text Key: 225490707
• Report Number: 1213643-2020-11477
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2004
• Device Catalogue Number: 0112680
• Device Lot Number: 43FJD141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/1999
• 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): Life Threatening; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 77