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

Catalog Number	0115191
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Unspecified Infection (1930); Necrosis (1971); Hernia (2240)
Date of Event	06/09/2009
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.This emdr represents the bard/davol dulex mesh (device #2).An additional supplemental emdr was submitted to represent the bard/davol composix kugel mesh (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: (b)(6) 2004 - patient was diagnosed with incarcerated ventral hernia thereby underwent laparoscopic converted to open repair with implant of composix kugel mesh (device 1).Per op notes, ¿adhesions were lysed.There were multiple hernia defects that were noted and reduced.The small bowel diverticulum was noted and resected.The hernia defects with omentum were reduced.A composix kugel mesh (device 1) was placed and sutured.¿ (b)(6) 2006 - patient was diagnosed with recurrent ventral hernia and abdominal mass thereby underwent open repair with excision of composix kugel mesh (device 1) and implant of synthetic mesh.Per op notes, ¿the scar was excised.Purulent material was noted and drained.Necrotic fat was excised.The mesh was noted and excised entirely.The defect was identified and repaired with synthetic mesh.¿ (b)(6) 2007 - patient was diagnosed with non-healing wound thereby underwent open repair with excision of scar, debridement of fascia and hernia repaired with sutures.(b)(6) 2009 - patient was diagnosed with incarcerated ventral hernia thereby underwent laparoscopic repair with implant of dulex mesh (device 2).Per op notes, ¿large scar was noted and excised.Adhesions were lysed.Multiple hernia defects were noted and reduced.A dulex mesh (device 2) was placed and sutured.¿ (b)(6) 2009 - patient was diagnosed with infected mesh and recurrent ventral hernia thereby underwent open repair with excision of dulex mesh (device 2) and implant of allomax (device 3).Per op notes, ¿the cutaneous scar and necrotic tissues were excised.Adhesions from prior mesh (device 2) were lysed.The mesh (device 2) was excised.The ventral hernia was noted and repaired with allomax mesh (device 3) using sutures.¿.

• Brand Name: MESH - DULEX
• 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): BRIDGER BIOMED, INC. -3031159; 2430 north 7th avenue; bozeman 59715
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 23727465
• Report Number: 1213643-2025-01166
• Device Sequence Number: 18696030
• Product Code: FTL
• UDI-Device Identifier: 00801741011849
• UDI-Public: (01)00801741011849(10)BRSK8315
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K003917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2009
• 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 Catalogue Number: 0115191
• Device Lot Number: BRSK8315
• 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: 12/05/2025
• 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: 59 YR
• Patient Sex: Male