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

Catalog Number	5954600
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Bacterial Infection (1735); Impaired Healing (2378)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Attorney alleges that the patient underwent umbilical hernia repair with implant of ventralex st on (b)(6) 2022.It was alleged that the patient had clinical signs of infection including a non-healing umbilical wound, persistent yellow/green drainage, malodorous drainage, imaging with phlegmon/ abscess, exposed mesh from umbilical incision site and removal of mesh on (b)(6) 2022.During this procedure the patient was implanted with a ventralight st mesh.Due to the mesh being improperly placed in a contaminated field, this revision surgery was further complicated by nonhealing, draining wound, post operative abscess with myositis necessitating drain placement, cultures with staph, diphtheroid necessitating antibiotic therapy and removal of mesh on (b)(6) 2023.Due to unincorporated mesh and mesh infection with mycobacterium fortuitum making further antibiotic therapy necessary.As alleged, the patient experienced additional surgical intervention, adhesion, disability, recurrence and chronic pain.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including infection, abscess, impaired healing and mesh explant.The instructions-for-use supplied with the device list infection as possible complication.The warning section of the ifu 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 device".A review of the manufacturing records was performed and found that the lot was manufactured to specification.This emdr represents ventralight st mesh (device #2).An additional emdr was submitted to represent ventralex st (device #1).Should additional information be provided, a supplemental emdr will be submitted.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: 22209729
• Report Number: 1213643-2025-00486
• Device Sequence Number: 20987730
• Product Code: FTL
• UDI-Device Identifier: 00801741031632
• UDI-Public: (01)00801741031632(17)221028(10)HUEY1642
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

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: 10/28/2022
• Device Catalogue Number: 5954600
• Device Lot Number: HUEY1642
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Disability
• Patient Sex: Female