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

Catalog Number	5954450
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Purulent Discharge (1812); Impaired Healing (2378); Drug Resistant Bacterial Infection (4553)
Date of Event	03/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 5 years 3 months post implant of ventralight st, patient was diagnosed with bacterial infection, impaired healing, purulent discharge & mesh migration thereby underwent repair with mesh removal.The instructions-for-use supplied with the device list infection &mesh migration as possible complications.Review of manufacturing records confirms product was manufactured to specification.In regard to infection, the warnings section in ifu states, "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 mesh." this emdr represents the ventralight st mesh (device #2).An additional supplemental emdr was submitted to represent the mesh ¿ composix kugel (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 information provided: (b)(6) 2010 - patient was diagnosed with incisional hernia (x4) thereby underwent laparoscopic repair with implant of composix kugel mesh (device #1).Per operative notes, ¿the hernias were identified, there was omental fat within these which were reduced.A composix kugel mesh (device #1) was advanced into peritoneal cavity placed at the level of umbilicus and tacked to cover all anterior abdominal hernias.¿ (b)(6) 2016 - patient was diagnosed with anterior abdominal wall infection and enterocutaneous fistula thereby underwent repair with removal of mesh (device #1).Per operative notes, ¿there was a wound draining serous to bilious looking fluid just above the umbilicus and a large portion of mesh (device #1) seen involved in infection.The small intestine was adhesed to mesh specifically 2 portions of jejunum had fistulized to mesh with open intestine and succuss leaking out.After most of the mesh and tacks were removed some of it was left as there was significant adhesion of colon and were not infected.Piece of intestine was removed, and anastomosis was created with suture.¿ (b)(6) 2017 - patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with implant of ventralight st mesh (device #2).Per operative notes, ¿cleared a small shallow ventral hernia and a ventralight st (device #2) mesh was tacked to abdominal wall covering the defect.¿ (b)(6) 2023 to (b)(6) 2024 - patient had multiple visits for infected abdominal mesh, purulent drainage, non-healing wound care, site drainage, had small piece of mesh removed (device #2) on (b)(6) 2023 and complaints of ¿mesh migrating through skin¿.Attorney alleges that the patient had adhesions, bowel perforation, bowel removal, fistulae, infection, mesh migration, hernia recurrence, pain and emotional injuries.Also alleged that patient had wound vac, adynamic ileus and an additional surgery on (b)(6) 2017.

• Brand Name: VENTRALIGHT ST 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: 21546146
• Report Number: 1213643-2025-090128
• Device Sequence Number: 12775149
• Product Code: FTL
• UDI-Device Identifier: 00801741031618
• UDI-Public: (01)00801741031618
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2025

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 Catalogue Number: 5954450
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 03/07/2025
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 186 KG