MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Ventralight ST w/ Echo; Surgical Mesh

Catalog Number	5955600
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	07/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2009- patient was diagnosed with incarcerated incisional hernia thereby underwent open repair with implant of ventralex mesh (device 1).Per op notes, "through upper midline incision, hernia sac with incarcerated omentum was identified in the abdominal region which was then reduced.A ventralex mesh (device 1) was placed intraperitoneally and was sutured." on (b)(6) 2011- patient was diagnosed with chronic pelvis pain, adhesion, thereby underwent robotic assisted laparoscopic repair.Per op notes, "adhesions from omentum to the anterior abdominal wall was identified.Adhesions were lysed and the omentum was reduced." on (b)(6) 2011- patient was diagnosed with abdominal pain, adhesion, thereby underwent laparoscopic repair.Per op notes, "extensive adhesion from the omentum to the previous hernia repair in mid upper abdomen." on (b)(6) 2012- patient was diagnosed with pelvic pain, adhesion, thereby underwent robotic assisted laparoscopic repair.Per op notes, "dense adhesions from the omentum to the anterior abdominal wall were identified and the adhesions were lysed." on (b)(6) 2014- patient was diagnosed with umbilical hernia, thereby underwent explant of ventralex mesh (device 1).Per op notes, "hernia sac in the umbilical region with incarcerated omentum.Omentum was reduced and the hernia sac was dissected.The scar tissue was excised.The ventralex mesh (device 1) was folded at the top and the mesh (device 1) was excised." on (b)(6) 2015- patient was diagnosed with incisional hernia, thereby underwent laparoscopic repair with implant of synthetic mesh.Per op notes, "adhesions were lysed in abdominal region and the synthetic mesh was placed and tacked." on (b)(6) 2015- patient was diagnosed with recurrent epigastric incisional hernia, pain, thereby underwent laparoscopic repair with implant of ventralight st using echo ps (device 2).Per op notes, "recurrent hernia was noted in the abdominal region.A large ventralight st using echo ps (device 2) was placed over the previous synthetic mesh and was tacked with capsure tacking device." on (b)(6) 2017- patient was diagnosed with epigastric hernia, thereby underwent laparoscopic repair with implant of synthetic mesh.Per op notes, "multiple adhesions in abdominal region were lysed.The hernia was easily identified above and to the left of the previous upper mesh.A synthetic mesh was placed laterally and was tacked.".
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.This emdr represents the ventralight st using echo ps (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: Ventralight ST w/ Echo
• 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: 50050074
• Report Number: 1213643-2026-00954
• Device Sequence Number: 9617292
• Product Code: FTL
• UDI-Device Identifier: 00801741031731
• UDI-Public: (01)00801741031731
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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 Catalogue Number: 5955600
• 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: 07/20/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female
• Patient Weight: 219 LB