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

Catalog Number	5990011
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	03/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent a laparoscopic ventral hernia repair procedure with the implant of ventralight st mesh w/ echo ps 2 on (b)(6) 2025.It was reported that the patient has had abdominal pain since the procedure and now has "foul-smelling urine." contact reports the pain "shoots up the side of her abdomen while eating food." the patient recently had a fall and has issue with walking from another chronic condition.Reportedly, the surgeon told the patient that she had a lot of scar tissue in the area of where the mesh was implanted which had to be removed prior to implant.Patient had a follow up with her surgeon on (b)(6) 2025.As reported the patient "does not want to accuse anything until her follow with the surgeon that did the mesh repair." (note, the results of the follow-up appointment have not been reported to bd).
Additional Manufacturer Narrative
As reported, the patient experienced abdominal pain post implant of a ventralight st mesh w/ echo ps 2.Based on the information obtained to date, no conclusions can be made as to the degree to which the implant may have caused or contributed to the reported patient postoperative condition.Pain is a known inherent risk of surgery, and the instructions-for-use supplied with the device, lists pain as a possible complication.A review of the manufacturing records finds the lot was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of 190 units.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: 21881848
• Report Number: 1213643-2025-00341
• Device Sequence Number: 20990431
• Product Code: FTL
• UDI-Device Identifier: 00801741130977
• UDI-Public: (01)00801741130977(11)240930(17)260728(10)HUJW1805
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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,Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2025

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: 07/28/2026
• Device Catalogue Number: 5990011
• Device Lot Number: HUJW1805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• 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: Female