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

Catalog Number	0112660
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	06/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per the medical records review, about 1 month post implant of bard flat mesh, patient was diagnosed with wound infection and mesh migration thereby underwent removal of mesh.Regarding infection, the warning section of the ifu states that, "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." this emdr represents bard flat mesh (device #2).A supplemental emdr was submitted to represent mesh ¿ ventralex (device#1).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 or Problem Description
Per medical records: (b)(6) 2014 - patient was diagnosed with incarcerated ventral hernia thereby underwent open repair with implant of ventralex mesh (device #1).Per operative notes, ¿the hernia sac and incarcerated omentum were identified and reduced.A ventralex mesh (device#1) was then placed in an underlay fashion with sutures.Seprafilm was placed underneath to help prevent with any adhesions.¿ (b)(6) 2015 - patient was diagnosed with internal hemorrhoids thereby underwent screening colonoscopy.(b)(6) 2017 - patient was diagnosed with recurrent ventral hernia thereby underwent repair with removal of mesh (device #1) and implant of bard flat mesh (device #2).Per operative notes, ¿dissection was difficult secondary to prior mesh, multiple adhesions, significant scar tissue and mesh being folded over on itself.Once the mesh (device #1) was removed, were able to dissect and carefully separated from the adhered piece of bowel.A piece of bard flat mesh (device #2) which was secured in place with suture to the rectus muscle and anterior sheath.Mesh was noted to be iying in flat and adequate position.An additional piece of bard flat mesh was laid over the anterior sheath and overlay fashion, the tails of the for anchoring sutures for the retro rectus mesh were fed through this overlay mesh and tied down securely.¿ (b)(6) 2017 - patient was diagnosed with wound infection thereby underwent explantation of mesh (device #2), excisional debridement of anterior abdominal wall skin and subcutaneous tissue, washout of wound.Per operative notes, ¿it was noted that the overlay mesh (device #2) had partially pulled away from the fascia and mesh was excised.This excisional debridement was taken down to the subcutaneous tissues.¿ attorney alleges that the patient had abscess, adhesions, infections, mesh migration, pain, seroma, emotional injuries, depression and abdominal disfigurement.

• Brand Name: BARD FLAT MESH
• Common Device Name: 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: 18892134
• Report Number: 1213643-2024-091107
• Device Sequence Number: 20366162
• Product Code: FTL
• UDI-Device Identifier: 00801741016516
• UDI-Public: (01)00801741016516
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2021
• Device Catalogue Number: 0112660
• Device Lot Number: HUAX2094
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 98 KG