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	Abdominal Pain (1685); Adhesion(s) (1695)
Date of Event	03/02/2020
Type of Reportable Event	Serious Injury
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-jan-2017) is considered to be a best estimate.This emdr represents the ventralex st mesh (device 3).Additional supplemental emdrs were submitted to represent the ventralex st mesh (device 1 & 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.
Event or Problem Description
Per information provided: on (b)(6) 2017 - patient was diagnosed with ventral hernia thereby underwent laparoscopic repair with implant of ventralex st mesh (device 1).Per operation notes, "adhesions in abdominal region were lysed and a ventral hernia defect was identified.A ventralex st mesh (device 1) was placed and tacked." on (b)(6) 2017 - patient was diagnosed with multiple ventral hernia, thereby underwent laparoscopic repair with implant of ventralex st meshes (device 2 and 3).Per operation notes, "once ventral hernia was identified, it was excised.A ventralex st mesh (device 2) was placed in anterior abdominal wall and tacked.Then a supraumbilical hernia defect was identified and repaired by placing a piece of ventralex st mesh (device 3) and tacked." on (b)(6) 2020 - patient was diagnosed with upper abdominal pain, thereby underwent laparoscopic repair.Per operation notes, "extensive adhesions with omentum stuck to anterior abdominal wall was identified and lysed.No evidence of other ventral hernias.".

• 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 ; 8005566756
• MDR Report Key: 25649365
• Report Number: 1213643-2026-00800
• Device Sequence Number: 9728850
• Product Code: FTL
• UDI-Device Identifier: 00801741031489
• UDI-Public: (01)00801741031489(17)190328(10)HUBN1759
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

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: 03/28/2019
• Device Catalogue Number: 5950008
• Device Lot Number: HUBN1759
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2017
• 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 Age: 57 YR
• Patient Sex: Male