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

Catalog Number	0010302
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Bacterial Infection (1735); Fistula (1862)
Date of Event	08/09/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Based on the medical record review, post implant of ventralex meshes (device #1, #2), patient had bacterial infection, cutaneous fistula, cellulitis, abscess, thereby underwent laparoscopic repair with the removal of meshes (device #1, #2).Per plaintiff profile form, patient had abscess, seroma, chronic infection, cellulitis, abdominal draining and alleges patient death.No information regarding patient¿s death in the medical records provided to date and no autopsy report, or death certificate have been provided." 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-feb-2008) is considered to be a best estimate.This emdr represents the bard mesh - ventralex (device #2).An additional supplemental emdr was submitted to represent the bard mesh - ventralex (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.
Event or Problem Description
Per information provided: on (b)(6) 2008 ¿ patient was diagnosed with recurrent ventral hernia above umbilicus thereby underwent open repair with ventralex mesh (device #1, #2).Per op notes, ¿a ventralex patch (device #1) was placed into preperitoneal pocket and sutured.Then, prudent trocar site was repaired using ventralex patch (device #2) placed between the fascia and the peritoneum and secured using sutures catching a portion of underlying mesh (device #1).¿ on (b)(6) 2015 ¿ patient was diagnosed with cellulitis and abscess thereby underwent incision & drainage of abscess.Per notes, ¿a small amount of serous fluid was obtained, and antibiotics were provided.¿ on (b)(6) 2016 ¿ patient was diagnosed with infected umbilical mesh with cutaneous fistula thereby underwent laparoscopic repair with the removal of meshes (device #1, #2).Per op notes, ¿a old cutaneous defects eroded through the abdominal wall and mesh (device#1, #2) were noted.The mesh (device #1, #2) imbedded into fascia was removed completely.Peritoneum had chronic granulation tissue was excised.¿ attorney alleges that the patient passed away on (b)(6) 2017.

• Brand Name: MESH - VENTRALEX
• 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: 22466860
• Report Number: 1213643-2025-00605
• Device Sequence Number: 20796747
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479(17)130428(10)HUSB1712
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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: 04/28/2013
• Device Catalogue Number: 0010302
• Device Lot Number: HUSB1712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2008
• 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: Death
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 116 KG