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

Catalog Number	5954790
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Scar Tissue (2060)
Date of Event	08/24/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2015- patient underwent hernia repair with implant of 3dmax mesh (device 1) (note: there is no information provided regarding 3dmax in medical records and plaintiff profile form).(b)(6) 2016- patient was diagnosed with incisional hernia thereby underwent repair with implant of ventralight st.(ppf/mrr) (note: there is no operative notes provided for this procedure in medical records).(b)(6) 2016- patient underwent partial removal of infected 3dmax mesh (device 1) and ventralight st mesh (device 2) (ppf) (note: there is no operative notes provided for this procedure in medical records).(b)(6) 2017- attorney alleges removal of 3dmax mesh (device 1) and ventralight st mesh (device 2).(ppf) (note: there is no operative notes provided for this procedure in medical records).
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-jul-2014) is considered to be a best estimate.This emdr represents the bd ventralight st mesh (device 2).An additional supplemental emdr was submitted to represent the bd 3dmax (device 1).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: 23434083
• Report Number: 1213643-2025-01043
• Device Sequence Number: 8689481
• Product Code: FTL
• UDI-Device Identifier: 00801741031663
• UDI-Public: (01)00801741031663(17)160728(10)HUYG0528
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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: 07/28/2016
• Device Catalogue Number: 5954790
• Device Lot Number: HUYG0528
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2014
• 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 Age: 61 YR
• Patient Sex: Male