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

Catalog Number	0112720
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	01/18/2018
Type of Reportable Event	Serious Injury
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-sep-2015) is considered to be a best estimate.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 additional information provided: (b)(6) 2012 ¿ patient was diagnosed with incarcerated incisional hernia thereby underwent open repair with the implant of ventralex st mesh (device 1).Per op notes, ¿the defect was tucked back intraabdominally.A medium dual sided ventralex st mesh (device 1) was placed in underlay fashion and sutured.¿ (b)(6) 2014 ¿ patient had chronic purulent drainage and was diagnosed with infected mesh, recurrent umbilical hernia thereby underwent open repair with the removal of mesh (device 1).Per op notes, ¿there was clear purulent drainage from the umbilicus and from the fascia itself.The infected mesh (device 1) was removed in its entirety.There was evidence of a recurrent umbilical hernia as well where a piece of preperitoneal fat was slipping up over the mesh was removed and closed using sutures.¿ (b)(6) 2016 ¿ patient was diagnosed with incisional hernia thereby underwent open repair with the implant of bard flat mesh (device 2).Per op notes, ¿hernia sac was dissected free from the subcutaneous tissue and truncated at the fascial edge.Adhesions between bowel omentum and anterior abdominal wall was cleared up.A bard flat mesh (device 2) was placed into retrorectus space using sutures.¿ (b)(6) 2018 - patient was diagnosed with incarcerated incisional hernia thereby underwent open repair with the implant of bard flat mesh (device 3).Per op notes, ¿hernia sac was dissected free and intraabdominal contents were placed back.Then, placed a bard flat mesh (device 3) posterior to fascia using sutures.¿.

• Brand Name: BARD FLAT 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: 23716525
• Report Number: 1213643-2025-01162
• Device Sequence Number: 8909988
• Product Code: FTL
• UDI-Device Identifier: 00801741016561
• UDI-Public: (01)00801741016561(17)200928(10)HUZI1234
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2025

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: 09/28/2020
• Device Catalogue Number: 0112720
• Device Lot Number: HUZI1234
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2015
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 114 KG