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

Catalog Number	5955810
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the ventralight st w/ echo ps inflation tube broke and the yellow anchor detached, which was unable to be retrieved.The sample is not available for return.It is possible that closing the defect prior to pulling the inflation tube up through the abdomen may have contributed to the issue that presented.However, based on the information provided and without having the sample to evaluate, root cause cannot be determined.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.
Event or Problem Description
As reported, during an incisional hernia repair procedure using a ventralight st w/ echo ps the surgeon closed the defect with suture prior to pulling the inflation tube up against the abdominal wall.As reported the inflation tube broke and the yellow anchor detached when pulled up against the abdominal wall.Reportedly, the yellow anchor was unable to be retrieved, and was left in vivo.The procedure was able to be completed using the same mesh.There was no patient injury.

• 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: 21687095
• Report Number: 1213643-2025-00221
• Device Sequence Number: 13070014
• Product Code: FTL
• UDI-Device Identifier: 00801741031786
• UDI-Public: (01)00801741031786(11)240812(17)260728(10)HUJV0743
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/07/2025

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: 07/28/2026
• Device Catalogue Number: 5955810
• Device Lot Number: HUJV0743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2024
• 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