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

Catalog Number	5950008
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Unspecified Infection (1930); Seroma (2069); Impaired Healing (2378)
Date of Event	08/09/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2016 ¿ patient was diagnosed with left upper quadrant trocar site incisional hernia, umbilical hernia thereby underwent laparoscopic repair with the implant of ventralex st meshes (device 1, 2).Per op notes, ¿the hernia defect was noted in left upper quadrant.A ventralex st mesh (device 1) was placed and laid against anterior abdominal wall using sutures.Attention to the umbilical hernia, a large ventralex st mesh (device 2) was placed against the hernia defect using sutures.¿ (b)(6) 2016 ¿ patient had adhesions thereby underwent open repair with the lysis of adhesion.Per op notes, ¿adhesion to the mesh (device 2) in umbilicus was lysed.The mesh was divided.¿ (b)(6) 2016 ¿ patient was diagnosed with nonhealing midline abdominal wound thereby underwent open repair.Per op notes, ¿the fluid filled at the superior aspect of wound.The pus was drained.Nonviable tissues were debrided.¿ (b)(6) 2017 ¿ patient had chronic drainage and was diagnosed with non healing surgical wound, mesh infection thereby underwent open repair with the removal of mesh.Per op notes, ¿the chronic drainage was noted.All the mesh was excised.Due to incorporation of mesh, patient umbilicus and fascia was excised.A biological mesh was placed on the top of fascia using staples.¿.
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 mdr represents the ventralex st (device 2).An additional supplemental emdr was submitted to represent the ventralex st (device 1).Note, the manufacturing date (15-nov-2015) is considered to be a best estimate.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: Ventralex ST
• 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: 50436342
• Report Number: 1213643-2026-01095
• Device Sequence Number: 9167900
• Product Code: FTL
• UDI-Device Identifier: 00801741031489
• UDI-Public: (01)00801741031489(17)180128(10)HUZK1841
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2026

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: 01/28/2018
• Device Catalogue Number: 5950008
• Device Lot Number: HUZK1841
• 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: 08/13/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2015
• 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