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

Catalog Number	0112680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240)
Date of Event	07/19/2007
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2003, patient was diagnosed with multiple ventral hernias thereby underwent open repair with implant of bard flat mehs (device 1).Per operation notes, "three hernia sacs were identified and dissected free.The hernia sacs were entered and evacuated the omentum.Adhesions between hernia sac and omentum were lysed.The hernia sacs were connected.A bard flat mesh (device 1) was placed and sutured." on (b)(6) 2006, patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with implant of composix e/x (device 2) and ventralex mesh (device 3).Per operation notes, "previous incision was opened.The hernia sac contains omentum was taken down.The defect was just to the right of midline just above the umbilicus.There was a slight eventration of abdominal wall with overlying mesh (device 1) still present creating a hernia recurrence.A composix e/x (device 2) and ventralex mesh (device 3) were placed to cover the defect and sutured." on (b)(6) 2007, patient was diagnosed with recurrent ventral hernia with infected hernia mesh thereby underwent open repair with removal of bard flat mesh (device 1), composix e/x (device 2) and ventralex mesh (device 3).Per op notes, "incision was made through the previous hernia.Dense fibrous hernia sac over the top of the exposed old mesh (device 1, 2 and 3) were opened.There was fair amount of fluid along with some chronic inflammatory tissues were noted.This was swept away from the mesh.The omentum adherent to prior mesh was taken down.The infected ventral hernia meshes (device 1, 2 and 3) were excised and removed entirely.The residual sac was excised.The defect was repaired using sutures.".
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.This emdr represents the bard flat mesh (device 1).Additional supplemental emdrs were submitted to represent the mesh - composix e/x (device 2) and ventralex mesh (device 3).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: 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: 25171999
• Report Number: 1213643-2026-00634
• Device Sequence Number: 13311892
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530(10)43HND064
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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 Catalogue Number: 0112680
• Device Lot Number: 43HND064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/14/2026
• 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
• Patient Age: 47 YR
• Patient Sex: Female