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

Model Number 0112680

Device Problems Defective Device (2588); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Pain (1994); Hernia (2240); Disability (2371)

Event Date 10/29/2010

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.Based on the information provided, it is alleged "the patient underwent an additional surgery to repair the hernia defect." it is unclear at this time if the hernia defect repaired post implant of the mesh was a recurrence of the original hernia defect or a new hernia defect, however, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.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.

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2007 - the patient underwent surgery for repair of a ventral hernia, a bard davol "marlex" reference number (b)(4), lot number 43cqd058 was implanted to repair the hernia defect.On (b)(6) 2010 - the patient underwent an additional surgery for recurrence repair.The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.Based on the information provided, it is alleged "the patient underwent an additional surgery to repair the hernia defect." it is unclear at this time if the hernia defect repaired post implant of the mesh was a recurrence of the original hernia defect or a new hernia defect, however, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Addendum: this supplemental emdr is submitted to document additional information provided.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 6 years 2 months post implant of bard flat mesh, patient was diagnosed with hernia recurrence and abdominal pain thereby underwent repairs.Note: section a through f - 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.H3 other text : not returned.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2007 - the patient underwent surgery for repair of a ventral hernia, a bard davol "marlex" reference number 0112680, lot number 43cqd058 was implanted to repair the hernia defect.(b)(6) 2010 - the patient underwent an additional surgery for recurrence repair.The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.Addendum per additional information provided: (b)(6) 2007 - patient was diagnosed with ventral hernia thereby underwent open repair with the implant of bard flat mesh.Per operative notes, ¿the hernia was dissected free and easily reduced into the peritoneal cavity.A segment of bard flat mesh was then placed and secured.Redundant mesh was excised.¿ (b)(6) 2010 - patient visited hospital for abdominal pain.(b)(6) 2010 - patient was diagnosed with recurrent incarcerated ventral incisional hernia thereby underwent laparoscopic repair.Per operative notes, ¿hernia sac was identified in the right upper quadrant and was found to be incarcerated with omentum.This was carefully taken down and the hernia contents were fully reduced.An oval-shaped synthetic mesh was placed and secured.¿ (note: there was no mention/visualization of bard flat mesh).(b)(6) 2013 - patient visited hospital for abdominal pain.(b)(6) 2013 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent repair.Per operative notes, ¿the underlying mesh was actually intact.There was herniated and incarcerated preperitoneal fat which were resected.¿ attorney alleged that the patient had adhesions, hernia recurrence, mesh migration, pain and emotional injuries.

• 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: 7153028
• MDR Text Key: 96005944
• Report Number: 1213643-2017-01132
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2011
• Device Model Number: 0112680
• Device Catalogue Number: 0112680
• Device Lot Number: 43CQD058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2006
• 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; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 68 KG