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

Catalog Number	0117016
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Obstruction/Occlusion (2422)
Date of Event	10/21/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2002 ¿ patient was diagnosed with ventral hernia thereby underwent open repair with implant of composix e/x mesh (device 1).Per operative notes, ¿a composix e/x piece of mesh (device 1) was placed in the subumbilicus and sutured.¿ (b)(6) 2003 ¿ patient was diagnosed with left side recurrent incisional hernia thereby underwent open repair with implant of composix kugel mesh (device 2) per operative notes, ¿the hernia sac was noted to the lateral attachment of the previous mesh (device 1) to abdominal wall.A composix kugel mesh (device 2) was placed in the defect and tacked.¿ (b)(6) 2005 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of composix kugel mesh (device 3).Per operative notes, ¿the medial wall of the defect consisted of the previously placed mesh.The hernia sac was reduced and the preperitoneal pocket is created.A composix kugel mesh (device 3) was placed into the pocket and centered beneath the defect using sutures.¿ (b)(6) 2005 ¿ patient was diagnosed with mass abdominal wall thereby underwent open repair with partial removal of mesh (device 1, 2, 3).Per operative notes, ¿there was a thick walled fibrous mass that has a hematoma and the mass itself from the underlying meshes (device 1, 2, 3) were removed.¿ (b)(6) 2008 ¿ patient was diagnosed with recurrent incisional hernia repair with bard composix kugel hernia patch (device #4) (note: there is no operative notes for this procedure).(b)(6) 2015 ¿ patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent open repair with removal of meshes (device 1, 2, 3, 4).Per operative notes, ¿the multiple pieces of meshes (device 1, 2, 3, 4) was curled over themselves.There were multiple areas where mesh plastered up to the colon and small bowel.Adhesions were lysed.All pieces of meshes were removed.The defect was measured, and a bard soft mesh (device 5) was placed and sutured.(b)(6) 2016 ¿ patient had pain and was diagnosed with small bowel obstruction there by underwent laparoscopic converted to open repair.Per operative notes, ¿several loops of bowel were adherent to other loops, and there were several areas of twisting and diving.There was a significant area of bowel that was dilated and matted.¿.
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 soft mesh (device 5).Additional supplemental emdrs were submitted to represent the bard mesh - composix e/x (device 1) and bard mesh - composix kugel (device 2) and emdrs were submitted to represent bard mesh - composix kugel (device 3 and 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 SOFT 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: 23035929
• Report Number: 1213643-2025-00835
• Device Sequence Number: 21164522
• Product Code: FTL
• UDI-Device Identifier: 00801741030932
• UDI-Public: (01)00801741030932
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

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: 0117016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/12/2025
• 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: 61 YR
• Patient Sex: Female