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

Catalog Number 0112660

Device Problem Defective Device (2588)

Patient Problems Neuropathy (1983); Pain (1994); Disability (2371)

Event Date 03/28/2014

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.Medical records provided to date do not include the implant or explant operative report for the bard mesh, therefore, no evaluation can be done in regards to the allegations of hole in a bladder and water in the lungs.With the current information available, no definitive conclusion can be made.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.The information provided by bard 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 bard.Not returned to manufacturer.

Event Description

The following is based on a review of limited medical records and the attorney's legal claim provided to davol by the patient's attorney: on (b)(6) 2011 - patient underwent implant of a bard flat mesh to repair a bladder prolapse.On (b)(6) 2011 - the patient presented to the er with complaints of bilateral leg pain.On (b)(6) 2014 - the patient underwent removal of the bard flat mesh, it was reported there was a little of the mesh that could not be removed.It was further reported that there was a hole in the patient's bladder and water in her lungs during the explant procedure which prevented full removal of the mesh.On (b)(6) 2014 - the patient was diagnosed with vaginal prolapse and underwent vaginal reconstruction, four corner bladder neck suspension, vaginal vault suspension and anterior/posterior colporrhaphy.The patient alleges having pain to the legs and lower back, inability to walk, with damage to the nerves in the legs (neuropathy), ligaments and veins damaged.Patient reports being disabled because of the mesh.

• 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: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 7302436
• MDR Text Key: 101146067
• Report Number: 1213643-2018-00404
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016516
• UDI-Public: (01)00801741016516
• 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: Attorney
• Type of Report: Initial
• Report Date: 02/28/2018

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: 05/28/2013
• Device Catalogue Number: 0112660
• Device Lot Number: HUSD1723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2008
• 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; Disability
• Patient Age: 69 YR
• Patient Weight: 76