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

Catalog Number	0010101
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060)
Date of Event	08/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2015, the patient was diagnosed with incarcerated umbilical, ventral hernia, large right inguinal hernia and small left inguinal hernia thereby underwent open repair with implant of kugel patch (right - device 1), kugel patch (left ¿ device 2) and ventralex st mesh (device 3).Per operative notes, ¿on the right side, posterior fascia was opened, and a moderate-sized direct hernia mass was reduced.A small oval kugel patch (right ¿ device 1) was contoured to the abdominal content.On the left side, a direct hernia was identified.A small oval kugel patch (left - device 2) was contoured to the abdominal content.The wound was closed.On the ventral umbilical hernia, a ventralex st mesh (device 3) was placed posteriorly, and the fascia was closed using sutures".On (b)(6) 2018 patient was diagnosed with perforated diverticulitis thereby underwent open repair with removal of ventralex st mesh (device 3).Per operative notes, ¿there was an extremely large mesenteric abscess noted.In the midline, where the anterior abdominal wall mesh was seen.The ventralex st mesh (device 3) was identified and removed¿.On (b)(6) 2018 patient was diagnosed with bilateral groin pain thereby underwent open repair with removal of kugel patch (right ¿ device 1) and kugel patch (left ¿ device 2).Per operative notes, ¿on the left side, there was a dense amount of scar tissue was noted.The kugel patch (left - device 2) was identified and removed.On the right side, similar approach was performed.The kugel patch (right ¿ device 1) was identified and removed¿.
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.Note, the manufacturing date (15 feb 2015) is considered to be a best estimate.This mdr represents the kugel patch (device 2).An additional supplemental emdr was submitted to represent the kugel patch (device 1).An additional mdr was submitted to represent the ventralex st 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: 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 ; 8005566756
• MDR Report Key: 23788637
• Report Number: 1213643-2025-01202
• Device Sequence Number: 21450082
• Product Code: FTL
• UDI-Device Identifier: 00801741016332
• UDI-Public: (01)00801741016332(17)200228(10)HUZB1931
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2025

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 Expiration Date: 02/28/2020
• Device Catalogue Number: 0010101
• Device Lot Number: HUZB1931
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2015
• 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: 60 YR
• Patient Sex: Male