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 Code	Adhesion(s) (1695)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient developed signs of bowel dilation and severe bowel adhesions post implant of ventralex st mesh.Photo evaluation finds the mesh was correctly implanted and adhesions were noted in some fold exposing the uncoated side of the mesh.However, the photo review did not assist in the root cause determination.Adhesions formation is known inherent risks of surgery/use of the device.The adverse reaction section of the instructions-for-use (ifu), supplied with the device identifies adhesions as a possible complication.Review of manufacturing records confirms product was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution.The surface orientation section of the ifu states, "it is extremely important that this mesh be oriented correctly to function as intended.The visceral side of the ventralex st hernia patch is designed to temporarily separate tissue surfaces and minimize tissue attachment to the mesh.Place the bioresorbable coated side of the mesh against those surfaces where minimal tissue attachment is desired, i.E.Against bowel or other visceral structures.The uncoated polypropylene mesh side should face the surface where tissue ingrowth is desired.The uncoated polypropylene mesh surface should never be placed against the bowel or other visceral structures." 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
As reported on (b)(6) 2025, ventralex st mesh was laparoscopically inserted for a paraumbilical hernia repair using a capsure fixation device.As reported the mesh was dipped in saline prior to insertion.It was deployed through a main 12mm port and lifted to the defect area using a suture passer.On (b)(6) 2025, the patient showed signs of bowel dilation, requiring another surgery.During this procedure, severe bowel adhesions were noted at the edge of the mesh.It was reported that adhesions were removed, and fat omentum was placed over to prevent recurrence of adhesion.As reported "patient is ok now".

• 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: 23028717
• Report Number: 1213643-2025-00829
• Device Sequence Number: 13216519
• Product Code: FTL
• UDI-Device Identifier: 00801741031489
• UDI-Public: (01)00801741031489(11)240223(17)260128(10)HUJP1186
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2025

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: 01/28/2026
• Device Catalogue Number: 5950008
• Device Lot Number: HUJP1186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2024
• 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: Male