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

Catalog Number 0010302

Device Problems Defective Device (2588); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Sepsis (2067); Peritonitis (2252); Bowel Perforation (2668)

Event Date 03/07/2014

Event Type  Injury  

Event Description

Per provided medical records: (b)(6) 2003 - patient was diagnosed with ventral incisional hernia and scheduled for incisional herniorrhaphy at colostomy site.Per operative notes "the hernia sac was identified." "an 11x14 composix (kugel) mesh (device #1) was inserted preperitoneally." "at this time, the fascial defect was then approximated over the mesh incorporating the marlex portion of the mesh.(b)(6) 2004 - patient was diagnosed with ventral incisional hernia in the periumbilical region and scheduled for incisional herniorrhaphy with mesh.Per operative notes " the contents of the hernia were freed up and reduced back into the abdominal cavity.A large ventralex mesh (device #2) was inserted and the marlex tabs were sutured to the anterior fascia.(b)(6) 2014 - patient was diagnosed with perforated viscus with sepsis, peritonitis and underwent exploratory laparotomy, extensive complex adhesiolysis and removal of abdominal wall mesh.Per operative notes "the patient had a clear hernia above her prior mesh repair." as we chipped away through mesh, we were able to excise some fragments and to mobilize bowel freely down and away from the mesh." we encountered at least 3 different types of mesh (device #1, device #2) in the abdominal wall at different levels that were carefully removed.

Manufacturer Narrative

No conclusions can be made.Based on the medical records provided by the patient's attorney over nine years post implant of the ventralex mesh (device #2) the patient was diagnosed with a perforated viscus and underwent surgery.The medical records indicate multiple layers of mesh were identified and removed.An additional hernia was noted, however, based on the anatomical location of the hernia a recurrence does not appear to have presented.The instructions-for-use (ifu) supplied with the device lists adhesions, and infection as possible complications.In regards 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 patch.An unresolved infection may require removal of the mesh." this emdr represents the ventralex mesh (device #2).A supplemental emdr was submitted to represents the composix kugel mesh (device #1).

• Brand Name: MESH ¿ VENTRALEX
• 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: 16215558
• MDR Text Key: 307802667
• Report Number: 1213643-2023-090253
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021736
• 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
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0010302
• Device Lot Number: 43GOD303
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening; Required Intervention; Disability
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 62 KG