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

Catalog Number 0112660

Device Problems Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problems Erosion (1750); Unspecified Infection (1930); Nerve Damage (1979); Internal Organ Perforation (1987)

Event Date 10/09/2019

Event Type  Injury  

Event Description

Attorney alleges that on (b)(6) 2012 the patient was implanted with a bard mesh (bard flat mesh) in the course of treating pelvic organ prolapse and stress urinary incontinences.It is alleged that further to the implant, the patient suffered severe complications following the surgeries including mesh erosion, mesh shrinking and hardening, vaginal and urethral erosion, infection, inflammation, vaginal scarring, severe pain, organ perforation, and severe nerve.Necessitating further reparative and removal surgery which occurred on (b)(6) 2019.It is alleged that subsequent to the latter surgery, the patient has continued to suffer permanent injuries and impairments, including scarring, disfigurement, chronic pain, injuries, losses, and severe permanent adverse health consequences.It is alleged that the patient had been treated with a course of hospitalization, diagnostic imaging, revision surgery, serum testing, antibiotics, analgesics, and rest.It is also alleged that the patient will require further invasive repair surgery, physiotherapy, rehabilitation, and medical care.It is alleged that the device was defective.

Manufacturer Narrative

No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including organ perforation, permanent injury, erosion, infection, inflammation, pain and surgical intervention for mesh explant.The instructions-for-use (ifu) supplied with the device lists inflammation as a possible complication.In regards to the infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." should additional information be provided, a supplemental emdr will be submitted.The information provided by bd 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 bd.

• 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: 13200843
• MDR Text Key: 284350164
• Report Number: 1213643-2021-09620
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016516
• UDI-Public: (01)00801741016516
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/08/2022

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: 05/28/2015
• Device Catalogue Number: 0112660
• Device Lot Number: HUUE0780
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/08/2022
• 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): Disability; Life Threatening; Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female