MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Ventrio Mesh; Surgical Mesh

Catalog Number	0010211
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6)2011 - patient was diagnosed with incarcerated ventral hernia with partial small bowel obstruction thereby underwent open repair with implant of ventralex mesh (device 1).Per op notes, "a semilunar infraumbilical incision was performed with identification of the hernia sac.The viable bowel was placed back within the abdomen.The incarcerated peritoneal fascia and the hernia sac was removed.The fascial defect was identified, dissected.A ventralex mesh (device1) was placed within the defect and secured with sutures." (b)(6)2013 - patient was diagnosed with moderate intraabdominal adhesions thereby underwent open repair with explant of ventralex mesh (device1).Per op notes, "a midline laparotomy incision was made.The previous umbilical hernia was identified.The two thirds of the previously placed ventralex mesh (device 1) was free floating within the abdomen was excised from the fascia and subcutaneous tissue.Multiple adhesions were excised from abdomen.The fascia was reapproximated with sutures.Splenectomy was performed." (b)(6)2013 - patient was diagnosed with large incisional hernia, abdominal pain, adhesions thereby underwent open repair with implant of ventrio mesh (device 2).Per op notes, "a midline incision was made.Multiple loops of the bowel were densely adhered to the sac, which was reduced and excised completely.The bilateral advancement flap was performed.A ventrio mesh (device 2) was placed within the abdominal cavity and secured with sutures." (b)(6)2020- patient was diagnosed with recurrent ventral incisional, adhesion thereby underwent laparoscopic repair with implant of composix l/p mesh (device 3).Per op notes, "dense adhesions identified throughout the anterior abdomen were taken down.The small bowel and omentum to the anterior abdominal wall were also taken down.The previous incisional hernia repair and five new incisional hernias were identified.The five new hernias were converted into one defect.A composix l/p mesh (device 3) was placed within the abdominal cavity and secured with tacks.".
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-apr-2012) is considered to be a best estimate.This emdr represents the ventrio mesh (device 2).An additional supplemental emdr was submitted to represent the ventralex mesh (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.

• Brand Name: Ventrio 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 ; +1(800)556-6756
• MDR Report Key: 50050310
• Report Number: 1213643-2026-00951
• Device Sequence Number: 15857336
• Product Code: FTL
• UDI-Device Identifier: 00801741016387
• UDI-Public: (01)00801741016387(17)150428(10)HUWD0708
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• 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): 07/22/2026

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: 04/28/2015
• Device Catalogue Number: 0010211
• Device Lot Number: HUWD0708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2012
• 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 Sex: Male