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

Catalog Number	0010105
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2016 - patient was diagnosed with incisional hernia thereby underwent open repair with the implant of ventrio st mesh (device 1) and kugel hernia patch (device 2).Per op notes, "a ventrio st mesh (device 1) and a kugel hernia patch (device 2) were placed to the abdominal wall using sutures." (b)(6) 2016 - patient was diagnosed with recurrent incisional hernia thereby underwent repair.Per op notes, "incision was made over the hernia defect, carried down through the subcutaneous tissue.A synthetic mesh was placed to the defect using sutures." (b)(6) 2017 - patient had abdominal wall abscess thereby underwent incision and drainage of abdominal wall abscess with excision of chronic cyst/abscess cavity.Per op notes, "there was purulent fluid, which was aspirated out." (b)(6) 2019 - patient was diagnosed with recurrent ventral hernia, infected mesh and small bowel obstruction thereby underwent repair with removal of mesh (device 1 and 2).Per op notes, "the anterior ventral incisional hernia where the prior mesh had broken down and separated in the midline.Performed lysis of adhesions, inflammatory mass of the meshoma were took down.Excised the chronically inflamed mesh (device 1 and 2) also meshoma.Then 2 synthetic meshes were placed." (b)(6) 2019 - patient had open abdominal wall wound thereby underwent placement of wound vac.
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 kugel hernia patch (device 2).An additional supplemental emdr was submitted to represent the ventrio st mesh (device 1).Note, the manufacturing date (15-aug-2015) is considered to be a best estimate.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: 24741223
• Report Number: 1213643-2026-00400
• Device Sequence Number: 8743957
• Product Code: FTL
• UDI-Device Identifier: 00801741016370
• UDI-Public: (01)00801741016370(17)200828(10)HUZH0906
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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 Expiration Date: 08/28/2020
• Device Catalogue Number: 0010105
• Device Lot Number: HUZH0906
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2015
• 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: 52 YR
• Patient Sex: Male