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

Catalog Number	5950007
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	08/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2017 - patient was diagnosed with incarcerated supraumbilical incisional hernia thereby underwent open repair with implant of ventra lex st mesh (device 1).Per op notes, "a longitudinal incision was made in the midline above the umbilicus at the previous incision and palpable bulge.The defect in the fascia was noted with incarcerated fat and contents were reduced.A ventra lex st mesh (device 1) was placed in the defect and secured with sutures." on (b)(6)2019 - patient was diagnosed with incarcerated upper abdominal incisional hernias and incarcerated umbilical hernia thereby underwent open repair with excision of ventra lex st mesh (device 1) and implant of ventra lex st mesh (device 3).Per op notes, "a longitudinal laparotomy incision was made in the upper midline abdominal area at the previous scar site.The hernias were identified.Multiple swiss cheese like hernias were noted in multiple quadrants of the abdomen at-least four to five.The ventra lex st mesh (device 1) was excised.The incarcerated fat was also dissected and removed.An incarcerated umbilical hernia was identified and repaired with sutures.A ventra lex st mesh (device 3) was placed through the defect and secured with sutures." note: there is no operative notes/information provided regarding ventra light st mesh (device 2) implanted procedure which is performed on (b)(6)2017 in ppf and medical records.
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-2017) is considered to be a best estimate.This emdr represents the ventralex st mesh (device 1).An additional supplemental emdr was submitted to represent the ventralight st mesh (device 2).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: 50050306
• Report Number: 1213643-2026-00950
• Device Sequence Number: 9617295
• Product Code: FTL
• UDI-Device Identifier: 00801741031472
• UDI-Public: (01)00801741031472(17)190528(10)HUBR0609
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2026

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: 05/28/2019
• Device Catalogue Number: 5950007
• Device Lot Number: HUBR0609
• 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: 04/15/2017
• 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