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

Catalog Number	5950008
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	04/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2012 - patient was diagnosed with ventral hernia thereby underwent open repair with the implant of ventralex st mesh (device 1).Per op notes, "an infraumbilical incision was made.The medium ventralex st mesh (device 1) was placed into the abdominal cavity using sutures." (b)(6) 2013 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the implant of ventralex st mesh (device 2).Per op notes, "an incision was made over the hernia in the supraumbilical area.A hernia sac was dissected out, a mediumventralex st mesh (device 2) was placed into the abdominal cavity using sutures." (b)(6) 2018 - patient was diagnosed with incisional hernia thereby underwent repair with the removal of old mesh (device 1 and 2).Per op notes, "a supraumbilical incision was made to expose the hernia sac in the disrupted previously paced mesh.The mesh (device 1 and 2) were removed, then a synthetic mesh was placed.".
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 mesh (device 1).An additional supplemental emdr was submitted to represent the ventralex st mesh (device 2).Note, the manufacturing date (15-aug-2012) 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: 50458139
• Report Number: 1213643-2026-01110
• Device Sequence Number: 9898021
• Product Code: FTL
• UDI-Device Identifier: 00801741031489
• UDI-Public: (01)00801741031489(17)140828(10)HUWH1061
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• 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: 08/28/2014
• Device Catalogue Number: 5950008
• Device Lot Number: HUWH1061
• 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: 08/18/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2012
• 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: Female