MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number	5992025
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, on (b)(6) 2025, a ventralight st mesh w/ echo 2 was used during a procedure.As reported the mesh was "placed on the second intestine." adhesions were observed approximately two weeks post-implantation.It was reported that the patient underwent surgical intervention and the adhesions between the mesh and the intestine were surgically removed.During this procedure there was no placement of an additional mesh.There was no patient injury, and the current status of the patient is stable with no ongoing issues.
Additional Manufacturer Narrative
As reported, patient developed mesh adhesions to the intestine two weeks post-implantation of ventralight st mesh (echo 2).Based on the information provided, no conclusion can be made.Per the instructions-for-use, supplied with the device, "it is extremely important that this product is oriented correctly to function as intended.The visceral coated side of ventralight¿ st mesh (which contains the echo 2¿ positioning system frame) is designed to temporarily separate tissue surfaces and minimize tissue attachment to the mesh.Place the bioresorbable, coated side against those surfaces where minimal tissue attachment is desired, i.E., against bowel or other visceral structures.The uncoated polypropylene mesh side must face the surface where tissue ingrowth is desired.The uncoated polypropylene mesh side should never be placed against the bowel or other visceral structures." a review of the manufacturing records was performed and found that the lot was manufactured to the specification.To date, this is the only complaint for the reported lot of 115 units released for distribution.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: VENTRALIGHT ST W/ ECHO 2
• 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: 22955768
• Report Number: 1213643-2025-00812
• Device Sequence Number: 18608890
• Product Code: FTL
• UDI-Device Identifier: 00801741131042
• UDI-Public: (01)00801741131042(11)240520(17)260328(10)HUJS1446
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2025

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: 03/28/2026
• Device Catalogue Number: 5992025
• Device Lot Number: HUJS1446
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2024
• 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: Unknown