MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Kugel Patch; Surgical Mesh

Catalog Number	0010102
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Sepsis (2067); Obstruction/Occlusion (2422)
Date of Event	11/23/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2004 - patient was diagnosed with recurrent ventral incisional hernia (x2) thereby underwent open repair with the implant of two kugel patch (device 1 and 2).Per op notes, "in the lower portion, hernia sac was encountered.The upper border of the fascial defect was noted to be the edge of the previous gore-tex patch repair.The patient had a history of a previous hernia repair with mesh.A medium kugel patch (device 1) was placed over the defect using prolene sutures.The fascia at the midline was closed; the gore-tex patch to the edge of the fascia, where it had pulled away.The upper portion of the scar was incised; the hernia sac was encountered.A large kugel patch (device 2) was placed beneath the previous gore-tex patch." (note: the previously placed gore-tex patch was unknown during this procedure) (b)(6) 2015 - patient was diagnosed with sepsis, small bowel obstruction and had abdominal pain thereby underwent lysis of adhesions.Per op notes, "two layers of abdominal wall mesh (device 1 and 2) were encountered into the abdomen.There were omental and small bowel adhesions to the abdominal wall mesh.Lysis of adhesions was performed.".
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 kugel patch (device 2).An additional supplemental emdr was submitted to represent the kugel patch (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.

• Brand Name: Kugel Patch
• 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 ; +1(800)556-6756
• MDR Report Key: 50078388
• Report Number: 1213643-2026-00967
• Device Sequence Number: 10219065
• Product Code: FTL
• UDI-Device Identifier: 00801741016349
• UDI-Public: (01)00801741016349(10)43AOD199
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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: 0010102
• Device Lot Number: 43AOD199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 07/30/2026
• 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 Sex: Female