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

Catalog Number	0112660
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Inflammation (1932); Hernia (2240); Fibrosis (3167)
Date of Event	10/15/2004
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2003- patient was diagnosed with massive incisional hernia, thereby underwent open repair with implant of bard flat mesh (device 1 and 2).Per op notes, ¿a large portion of hernia sac was identified in the abdominal region which was completely excised.A two 10 x 14 bard flat mesh (device 1 and 2) was placed in the defect region and sutured¿.(b)(6) 2004- patient was diagnosed with left ventral hernia, thereby underwent open repair with implant of bard composix kugel hernia patch (device 3) and partial explant of bard mesh (device 1 and 2).Per op notes, ¿facial defect identified in the left abdominal region and was dissected.Small bowel found adhesed to the bard flat mesh (device 1 and 2) was resected.A bard composix kugel hernia patch (device 3) was placed in the abdominal region and sutured¿.(b)(6) 2006- patient was diagnosed with massive ventral hernia, thereby underwent open repair with implant of composix mesh (device 4).Per op notes, ¿a large epigastric hernia was identified.Adhesiolysis was performed.A synthetic mesh was then placed in the defect and sutured.Due to suture break the synthetic mesh was removed and a composix mesh (device 4) was placed and sutured¿.(b)(6) 2006- patient underwent explantation of bard flat mesh (devices 1 and 2), bard composix kugel hernia patch (device 3), and composix mesh (device 4).
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 mdr represents the bard flat mesh (device 2).Additional supplemental emdr's were submitted to represent the bard flat mesh (device1) and composix kugel hernia patch (device 3).Additional mdr was submitted to represent the composix mesh (device 4).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: 23656154
• Report Number: 1213643-2025-01143
• Device Sequence Number: 10055015
• Product Code: FTL
• UDI-Device Identifier: 00801741016516
• UDI-Public: (01)00801741016516(10)43DLD036
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: 2004
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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 Catalogue Number: 0112660
• Device Lot Number: 43DLD036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 11/26/2025
• 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
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 132 KG