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

Catalog Number	5954600
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a laparoscopic ventral hernia repair procedure, the hydrogel (st) barrier coating came off entirely from the ventralight st mesh.Reportedly, the mesh was hydrated in saline (quick dip 1-3 seconds) and was rolled immediately with st coating inside.The hydrogel (st) barrier was peeling off after inserting through the 8mm robot trocar.The mesh was removed, and another mesh was used to complete the procedure.There was no patient harm or injury.
Additional Manufacturer Narrative
As reported, during a laparoscopic ventral hernia repair procedure, the hydrogel (st) barrier of ventralight st mesh was peeling off after inserting through the 8mm robot trocar.The sample was not available for evaluation.However, reportedly, the size of trocar used was an 8mm.Per ifu, the recommended trocar size for the ventralight st mesh (5954600) is 10mm.The separation of the hydrogel coating is likely the result of using a smaller size trocar then recommended.The ifu states: "a minimum sized trocar is recommended for the laparoscopic delivery of ventralight st mesh.Insert the mesh through the trocar using a rigid instrument, such as non-serrated 5 mm forceps; do not over force the mesh through the trocar.If ventralight st mesh is hydrated longer than 3 seconds and/or does not easily deploy through the trocar, replace the trocar and retry with the next available, larger sized trocar." a review of the manufacturing records for the reported lot number confirmed that the lot was manufactured in accordance with applicable specifications.To date, this is the only reported complaint for this lot of (b)(4) 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 MESH
• 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: 25124103
• Report Number: 1213643-2026-00604
• Device Sequence Number: 16136707
• Product Code: FTL
• UDI-Device Identifier: 00801741031632
• UDI-Public: (01)00801741031632(11)240719(17)260628(10)HUJU0951
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• 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): 04/21/2026

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: 06/28/2026
• Device Catalogue Number: 5954600
• Device Lot Number: HUJU0951
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2024
• 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