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

Catalog Number 0112720

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

Patient Problems Abscess (1690); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Seroma (2069); Disability (2371); Fibrosis (3167); Drug Resistant Bacterial Infection (4553)

Event Date 04/18/2006

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.Regarding infection, the warning section of the ifu states "if one 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." review of the device history records found lot was manufactured to specification.No anomalies identified.If additional information is obtained, a supplemental mdr will be submitted.Not returned.

Event Description

It is alleged by the patients attorney that on (b)(6) 2006, the patient underwent surgery for repair of a large epigastric hernia.As reported, a bard/davol marlex, (b)(4), lot number 43kpd179 was implanted to repair the hernia defect.It is alleged that on (b)(6) 2006, the patient underwent an additional surgery to remove infected hernia mesh.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.

Event Description

It is alleged by the patients attorney that on (b)(6) 2006, the patient underwent surgery for repair of a large epigastric hernia.As reported, a bard/davol marlex, reference number 0112720, lot number 43kpd179 was implanted to repair the hernia defect.It is alleged that on (b)(6) 2006, the patient underwent an additional surgery to remove infected hernia mesh.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) 2006 - patient was diagnosed with large epigastric hernia thereby underwent open repair with implant of bard mesh (bard flat mesh).Per operative notes, ¿a large hernia sac was identified and removed away.A bard mesh was placed and sutured.¿ (b)(6) 2016 - patient had hospital visit for catheter placement under ultrasound guidance.(b)(6) 2006 - patient was diagnosed with infected ventral hernia mesh thereby underwent repair with removal of mesh.Per operative notes, ¿all the pus was suctioned in an abscess cavity and then the mesh was removed from the anterior abdominal wall.¿ attorney alleges that the patient had abscess, pain, seroma, infections, emotional injuries and others such as removal, dizziness, and acid reflux.

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.Regarding infection, the warning section of the ifu states "if one 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." 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 the manufacturing date.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 3 months post implant of bard flat mesh, patient was diagnosed with infection, seroma, abscess, necrosis, inflammation and fibrosis thereby underwent repair with explant of mesh.The instructions-for-use supplied with the device lists seroma and inflammation as possible complications.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.

• 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: 7155073
• MDR Text Key: 96059796
• Report Number: 1213643-2017-01143
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016561
• UDI-Public: (01)00801741016561
• 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: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2010
• Device Catalogue Number: 0112720
• Device Lot Number: 43KPD179
• Was Device Available for Evaluation?: No
• Event Location: Home
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2005
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 81 KG