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

Catalog Number	0010301
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	01/26/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about few years post implant of ventralex mesh, patient was diagnosed with adhesions and hernia recurrence thereby underwent repair.The instructions-for-use supplied with the device lists adhesions and hernia recurrence as possible complications.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents bard/davol mesh ¿ ventralex (device #2).An additional supplemental emdr was submitted to represent bard/davol 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 by patient's attorney: on (b)(6) 2011 - patient was diagnosed with incarcerated umbilical hernia thereby underwent open repair with implant of ventralex mesh (device #1).Per operative notes, ¿hernia sac was noted with incarcerated and strangulated omentum, there was also a knuckle of small bowel that was obstructed.A piece of small bowel was dumped into the abdominal cavity for mobilization and ventralex mesh (device #1) was placed as an inlay underneath the fascia and stapled.On (b)(6) 2013 - patient was diagnosed with umbilical hernia thereby underwent open repair with implant of ventralex mesh (device #2).Per operative notes, "a small defect was noted in umbilicus.The hernia sac overlying this was excised and loop of small bowel was freed from surrounding this area.As there was no previous mesh in that location, another small ventralex mesh (device #2) was placed." on (b)(6) 2015 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with removal of ventralex mesh (device #1) and implant of ventralight st mesh using echo ps (device #3).Per operative notes, "multiple adhesions of small bowel were taken down from the mesh.Mesh was very adherent therefore the mesh (device #1) was cut in half and brought out of it.The knuckle of small bowel within the hernia was carefully reduced, placed a ventralight st mesh using echo ps (device #3) and tacked." attorney alleged that the patient had adhesions, bowel obstruction, pain, hernia recurrence and emotional injuries.

• Brand Name: MESH - VENTRALEX
• 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: 21909108
• Report Number: 1213643-2025-090175
• Device Sequence Number: 17165055
• Product Code: FTL
• UDI-Device Identifier: 00801741000355
• UDI-Public: (01)00801741000355
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2025

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: 0010301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 04/25/2025
• 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: 44 YR
• Patient Sex: Female