MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MESH ¿ COMPOSIX L/P; SURGICAL MESH

Catalog Number	0134810
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Fistula (1862)
Date of Event	07/17/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 5 months post implant of composix l/p, patient was diagnosed with bacterial infection, fistula, abscess, mesh migration and adhesions thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists adhesions and fistula as possible complications.The warning 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 removal of the device." note, the manufacturing date (15-aug-2009) is considered to be a best estimate.This emdr represents the mesh ¿ composix l/p (device #2).An additional supplemental emdr was submitted to represent the 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 information provided: (b)(6) 2012 - patient was diagnosed with incisional hernia thereby underwent open repair with the implant of ventralex (device #1).Per operative notes, ¿identified the hernia sac and was dissected down.A ventralex mesh (device #1) was then placed into the defect using prolene sutures.¿ (b)(6) 2012 - patient was diagnosed with acute abdominal pain with chronic abdominal wall hernias.(b)(6) 2013 - patient was diagnosed with large incisional hernia thereby underwent open repair with the implant of composix l/p mesh (device #2).Per operative notes, ¿there were numerous adhesions in the hernia sac, and these were taken down.A composix l/p mesh (device #2) was then placed and secured using prolene sutures.¿ (note: there was no mention/visualization of the previously placed ventralex mesh (device #1) during this procedure.) (b)(6) 2013 - patient visited hospital for abdominal abscess.(b)(6) 2013 - patient was diagnosed with infected abdominal wall mesh thereby underwent repair with removal of meshes (device #1 & #2).Per operative notes, ¿the incision was carried down along the fistula tract.The mesh was adherent to the abdominal wall, and this was taken down around all edges.All sutures were removed where the mesh was displaced.And this mesh was also involved in the purulent material.The mesh was completely removed.¿ attorney alleged that the patient had adhesions, infection, pain and hernia recurrence.

• Brand Name: MESH ¿ COMPOSIX L/P
• 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: 21372607
• Report Number: 1213643-2025-090076
• Device Sequence Number: 20947344
• Product Code: FTL
• UDI-Device Identifier: 00801741031311
• UDI-Public: (01)00801741031311(10)HUTH1605
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2025

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: 0134810
• Device Lot Number: HUTH1605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2009
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 135 KG