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

Catalog Number	5954450
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, about a week post implant of ventralight st mesh, the patient developed bacterial infection and underwent mesh explant.Based on the information reported, no conclusions can be made as to the degree to which the implant may have contributed to the patient¿s postoperative course.To date, this is the only reported complaint for this manufacturing lot.Postoperative infection is a known inherent risk of surgery and is included as a possible complication in the adverse reaction section of the instructions-for-use supplied with the device.Regarding infection the warnings section states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the mesh." 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 procedure the patient was implanted with ventralight st mesh on (b)(6) 2024.It was reported that a week later the patient developed bacterial infection.It was further reported that the patient underwent mesh explant on (b)(6) 2024 and the patient is doing fine now.
Additional Manufacturer Narrative
As reported, about a week post implant of ventralight st mesh, the patient developed bacterial infection and underwent mesh explant.Based on the information reported, no conclusions can be made as to the degree to which the implant may have contributed to the patient¿s postoperative course.To date, this is the only reported complaint for this manufacturing lot.Postoperative infection is a known inherent risk of surgery and is included as a possible complication in the adverse reaction section of the instructions-for-use supplied with the device.Regarding infection the warnings section states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the mesh." addendum: h11: this supplemental mdr is submitted to update the dhr results and to correct the udi.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 a procedure the patient was implanted with ventralight st mesh on (b)(6)2024.It was reported that a week later the patient developed bacterial infection.It was further reported that the patient underwent mesh explant on (b)(6)2024 and the patient is doing fine now.

• 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: 21112802
• Report Number: 1213643-2025-00001
• Device Sequence Number: 8733208
• Product Code: FTL
• UDI-Device Identifier: 00801741031618
• UDI-Public: (01)00801741031618(11)240216(17)260128(10)HUJP0834
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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: 01/28/2026
• Device Catalogue Number: 5954450
• Device Lot Number: HUJP0834
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2024
• 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: Unknown