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

Catalog Number UNKAA030

Device Problems Material Fragmentation (1261); Migration or Expulsion of Device (1395); Defective Device (2588)

Patient Problems Unspecified Infection (1930); Hernia (2240); Bowel Perforation (2668)

Event Date 08/10/2019

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made.The patient's attorney alleges bowel perforation, infection, hernia recurrence, mesh migration, fragmentation, fistula, pain, erythema and swelling requiring medical intervention; however, no details have been provided.Review of the adverse reaction section of the ifu states that adhesions, inflammation, extrusion, fistula formation, hernia recurrence, erosion and migration of the mesh are possible complications.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided a supplemental emdr will be submitted.

Event Description

Per patient email (pro-se): ¿i will be filing a lawsuit for my bard hernia mesh failure resulting in reconstructive major surgery damaged intestines, damaged liver, damaged bladder and adding an additional 8 new hernias from the sutures, pain and suffering since 2009, misdiagnosis for liver damage, not the hernia mesh, high blood pressure as a result of the mesh relocating migrating, a strangulated colon, a strangulated intestine as well as the new hernias are small but complicated areas near the liver and ribs.The surgeon may not be able to fix them, the extent of the internal organ damage is not yet known.The surgery must be performed with exploratory surgery.Major surgery to locate the missing migrated mesh.And investigate the open intestine repair it and search for other damages it caused to the liver and possibly the bladder as well.For 5 years now my blood pressure keeps rising.I am (b)(6) pounds, not overweight my liver was not the cause of the pain and suffering.Many years ago i had a fistula for my bladder and intestine.This also may be a result of the failed mesh.I have been told by the surgeon it will take a year to finish my surgeries if some are even possible.As a note, she said i may not be able to have all the new hernias repaired do to the complexity of the new hernias and locations all around the old mesh location the mesh has caused multiple emergency room visits over the years with no direct cause of the pain and was misdiagnosed many times as liver or pancreas and not the hernia mesh that was in the exact same place.2 doctors in (b)(6) and (b)(6) all had no idea of why the swelling and pain were there.It was only an emergency room visit to (b)(6) and the red rash looking ball and swelling that they took a closer look and found 1 new large hernia.After more tests in (b)(6) its found there are now over 8 verified and possible 12 new hernias in total from the migration of the old mesh.The surgery as any could result in my death.As my digestive tract must be removed to fish out the pieces of mesh that are evading parts of my body causing pain discomforts infections leaking of intestines and more.As i had a disagreement with 1 attorney already i decided to do this pro se, so i am fully aware i have bard mesh on the lawsuit list.Attached are just some of my doctor's visits.¿ per medical records: between (b)(6) 2019 and (b)(6) 2020 the patient had multiple visits to the hospital er, his primary care doctor¿s office and a consultation with a urologist with complaints of abdominal pain, epigastric pain and urinary issues.Per the primary care office visit notes on (b)(6) 2019, a recommendation to consult with a general surgeon with no reason documented.On (b)(6) 2019, the patient consulted with a surgeon as a new patient who ordered an ultrasound of the abdomen wall and lower back.The surgeon consultation details and the diagnostic test results were not included in the information received.

• 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: 9935800
• MDR Text Key: 190898370
• Report Number: 1213643-2020-03267
• Device Sequence Number: 1
• Product Code: FTL
• 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: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2020
• 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): Life Threatening; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 79