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

Catalog Number	5990015
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a laparoscopic incisional hernia repair using a ventralight st w/ echo 2 ps, the device was quickly dipped (1-3 sec) in saline prior to use.The mesh was then rolled per ifu with the st coating on the inside.The device was then inserted into a 12mm trocar.It was reported that after inserting it through the trocar, when pulling up against the patient's abdominal wall, the surgeon noticed the st coating was sloughed off in some areas.As reported, the surgeon removed the mesh, and a new mesh was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
As reported, separation of the sepra coating on the ventralight st mesh (echo 2) was noted after trocar insertion.An image of the mesh with the echo 2 frame still attached was provided.Review confirms there is a void in the st coating which presented while in use.This was not reported as an out of box condition.The photo does not assist in determining root cause.Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) 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: 21331885
• Report Number: 1213643-2025-00035
• Device Sequence Number: 7827166
• Product Code: FTL
• UDI-Device Identifier: 00801741130991
• UDI-Public: (01)00801741130991(11)240502(17)260328(10)HUJS0292
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2026
• Device Catalogue Number: 5990015
• Device Lot Number: HUJS0292
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2024
• 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: Other
• Patient Sex: Unknown