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); Nerve Damage (1979); Pain (1994); Hernia (2240); Disability (2371)

Event Date 10/27/2011

Event Type  Injury  

Manufacturer Narrative

To date, limited information has been provided.Based on the limited information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication.If additional information is obtained, a supplemental mdr will be submitted.Review of the device history records found lot was manufactured to specification.No anomalies identified.Not returned.

Event Description

It is alleged by the patients attorney that on (b)(6) 2009, the patient underwent surgery for repair of an open right inguinal hernia.As reported, a bard/davol marlex, (b)(4), lot number 43ard263 was implanted to repair the hernia defect it is alleged that on (b)(6) 2011, the patient underwent an additional surgery for excision of the marlex mesh and a recurrence repair.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective marlex.

Manufacturer Narrative

To date, limited information has been provided.Based on the limited information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication.If additional information is obtained, a supplemental mdr will be submitted.Review of the device history records found lot was manufactured to specification.No anomalies identified.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct manufacturing date.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per the medical records review, about few years post implant of bard flat mesh, patient was diagnosed with abdominal pain, nerve damage and hernia recurrence thereby underwent repair with mesh removal.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

It is alleged by the patients attorney that on 9/24/2009, the patient underwent surgery for repair of an open right inguinal hernia.As reported, a bard/davol marlex, reference number (b)(4), lot number 43ard263 was implanted to repair the hernia defect it is alleged that on 10/27/2011, the patient underwent an additional surgery for excision of the marlex mesh and a recurrence repair.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective marlex.Addendum per additional information provided: (b)(6) 2009 - patient was diagnosed with right inguinal hernia thereby underwent open repair with implant of bard flat mesh (device #1).Per operative notes, ¿identified a large lipoma of cord, an indirect sac and two small direct hernias which were replaced back into the preperitoneal space.Then laid a small piece of bard flat mesh (device #1) with a split for the spermatic cord and secured it using a tacker.¿ (b)(6) 2010 to (b)(6) 2011 - patient frequently visited hospital for abdominal pain.(b)(6) 2011 - patient was diagnosed with chronic right inguinal pain, possible ilioinguinal nerve entrapment thereby underwent open right groin exploration with excision of mesh and implanted with marlex mesh (device #2).Per operative notes, ¿the mesh was carefully excised (device #1).The ilioinguinal nerve was identified, divided and distally ligated.A marlex mesh (device #2) was placed over the floor of the canal and was sutured in place to the shelving edge of the inguinal ligament and around the internal ring.¿ (no product identifiers were provided for device #2).(b)(6) 2011 to (b)(6) 2012 - patient frequently visited hospital for chronic pain and swelling.Attorney alleges that the patient had nerve damage, pain, hernia recurrence, excision surgery 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: 7142398
• MDR Text Key: 95628636
• Report Number: 1213643-2017-01097
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2012
• Device Model Number: 0112680
• Device Catalogue Number: 0112680
• Device Lot Number: 43ARD263
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2007
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 64 KG