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

Catalog Number	5955600
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during the procedure, the echo ps could not be separated from the ventralight st w/ echo ps mesh when removal was attempted.The surgeon removed the mesh and used another one to complete the procedure.Evaluation of the sample finds no points of fixation on the mesh either by staple or suture that would suggest the mesh was not fixated first before attempting to remove the echo balloon.Ifu states, after inflating the balloon to position device, fixate the mesh using a fixation device or monofilament sutures to secure the mesh before removal of the balloon." a simulated use test was performed and after fixating fasteners to the mesh onto a foam pad, the echo ps balloon could be removed from the mesh with no resistance.No device problem or manufacturing anomalies were found.A review of manufacturing records was conducted and shows the product was manufactured 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.
Event or Problem Description
As reported, during a laparoscopic ventral hernia procedure on (b)(6) 2026, the surgeon was unable to remove the echo ps from the ventralight st w/ echo ps mesh.Reportedly, multiple attempts were made, but the components could not be disengaged as expected.The surgeon removed the mesh from the patient's body and used another one to complete the procedure.There was no patient injury/harm.

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 25135904
• Report Number: 1213643-2026-00611
• Device Sequence Number: 13131592
• Product Code: FTL
• UDI-Device Identifier: 00801741031731
• UDI-Public: (01)00801741031731(11)250912(17)270828(10)HUKW0489
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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 Catalogue Number: 5955600
• Device Lot Number: HUKW0489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2025
• 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