MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST MESH; SURGICAL MESH

Catalog Number	5954680
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Unspecified Infection (1930); Scar Tissue (2060); Hernia (2240); Fibrosis (3167)
Date of Event	08/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 6 years 1 month post implant of ventralight st mesh, patient was diagnosed with infection, hernia recurrence, fibrosis, abdominal pain, scar tissue thereby underwent surgical intervention.The instructions-for-use supplied with the device list infection, hernia recurrence, adhesions as a possible complication(s).The warnings section of the 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 the removal of the device.¿ review of manufacturing records confirms product was manufactured to specification.Note, the manufacturing date (15-dec-2010) is considered to be a best estimate.This emdr represents the ventralight st mesh (device #2).An additional supplemental emdr was submitted to represent the sepramesh ip (device #1) and additional emdr was submitted to represent the ventrio st mesh (device #3).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.
Event or Problem Description
Per information provided by patient¿s attorney and review of patient medical records: (b)(6)2009 - patient was diagnosed with ventral hernia thereby underwent open repair with the implant of sepramesh ip (device #1).Per operative notes, ¿there was a midline hernia and then at the inferior aspect of the wound was another large hernia.Adhesions were taken down.A sepramesh ip (device #1) was then placed posterior to the abdominal wall using sutures.¿ (b)(6)2011 - patient was diagnosed with large recurrent ventral hernia thereby underwent repair with partial removal of mesh (device #1) & implant of ventralight st mesh (device #2).Per operative notes, ¿identified the hernia sac and was excised.There was one loop of bowel which was more densely adherent to the mesh.This was taken down.Excising a small portion of the old mesh (device #1), which had been shrunken and crumpled up in the inferior aspect of the incision, where it had pulled away from the fascia from her previous repair.The defect was repaired with a ventralight st mesh (device #2) using prolene sutures.¿ (b)(6)2015 - patient was diagnosed with left flank incisional hernia thereby underwent repair with the implant of ventrio st mesh (device #3).Per operative notes, ¿encounter a fair amount of scar tissue and identified the hernia sac.Hernia was coming between the 2 floating ribs in the lower posterior flank.A ventrio st mesh (device #3) was secured in place using sutures.¿ (b)(6)2015 - patient had abdominal pain.(b)(6)2017 - patient was diagnosed with chronic sinus tract of the skin and flank hernia thereby underwent wound exploration and excision of infected sinus tract and suture.Per operative notes, ¿identified the tract through the flank and abdominal wall and this tracked into two sutures, which were removed.Identified the meshes (device #1, #2 & #3) which were completely incorporated and were not required to be removed.¿ attorney alleged that the patient had adhesions, fistulae, infection, mesh migration, mesh shrinkage, pain and hernia recurrence.Shrunken mesh crumpled up and pulled away.

• Brand Name: VENTRALIGHT ST MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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: 21705944
• Report Number: 1213643-2025-090138
• Device Sequence Number: 15940771
• Product Code: FTL
• UDI-Device Identifier: 00801741031656
• UDI-Public: (01)00801741031656(17)121228(10)HUUL0405
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2025

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 Expiration Date: 12/28/2012
• Device Catalogue Number: 5954680
• Device Lot Number: HUUL0405
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2010
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 91 KG