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 Code	Hernia (2240)
Date of Event	06/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2016 - patient was diagnosed with bilateral indirect type inguinal hernias thereby underwent open repair with implant of kugel patch (device 1 and 2).Per op notes, ¿an incision was made above the midpoint in the left inguinal ligament.A small indirect inguinal hernia sac was identified and reduced.A small kugel patch (device 1) was placed and secured with sutures.An incision was made in the right inguinal ligament.A small indirect hernia was noted on the right and reduced into the abdominal cavity.A small kugal patch (device 2) was placed and secured with sutures.¿ on (b)(6) 2018 - patient was diagnosed with recurrent bilateral inguinal hernias thereby underwent laparoscopic repair with implant of 3dmax mesh (device 3).Per op notes, ¿a left upper quadrant incision was made.Bilateral preperitoneal meshes (device 1 and 2) were identified.Bilateral medial recurrences were noted.On the left side, the inferior epigastric was completely fused with the mesh (device 1) near its insertion at the inguinal ring and it was divided.A 3dmax mesh (device 3) was placed and secured together at the midline with suture.¿.
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 patch (device 2).An additional supplemental emdr was submitted to represent the kugel patch (device 1).Note, the manufacturing date (15-oct-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: 24940426
• Report Number: 1213643-2026-00534
• Device Sequence Number: 5663498
• Product Code: FTL
• UDI-Device Identifier: 00801741016332
• UDI-Public: (01)00801741016332(17)201028(10)HUZJ0922
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: 10/28/2020
• Device Catalogue Number: 0010101
• Device Lot Number: HUZJ0922
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2015
• 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: 39 YR
• Patient Sex: Male