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); Hernia (2240)
Date of Event	08/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2016 - patient was diagnosed with bilateral inguinal hernia thereby underwent open repair with implant of kugel hernia patch (device #1 & #2).Per op notes, ¿the hernia sac on the left side was identified, dissected and reduced.A kugel hernia patch (device #1) was placed and sutured.The hernia sac on the right side was identified and reduced.A kugel hernia patch (device #2) was placed and sutured.¿ (b)(6) 2019 - patient was diagnosed with recurrent bilateral inguinal hernia with pain thereby underwent robotic assisted laparoscopic repair with implant of 3dmax light (device #3 & #4).Per op notes, ¿the prior mesh (device #1) in the left inguinal region appeared to be folded superiorly led to recurrence.The hernia sac was identified and repaired with 3dmax light (device #3) and sutured.The hernia sac in right side was identified and repaired using 3dmax light (device #4) and sutured.
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-sep-2015) is considered to be a best estimate.This emdr was submitted to represent the bard/davol kugel patch (device #2).Additional supplemental emdr represents the bard/davol 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 ; 8005566756
• MDR Report Key: 22724755
• Report Number: 1213643-2025-00727
• Device Sequence Number: 8288401
• Product Code: FTL
• UDI-Device Identifier: 00801741016332
• UDI-Public: (01)00801741016332(17)200928(10)HUZI0609
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/01/2025

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: 09/28/2020
• Device Catalogue Number: 0010101
• Device Lot Number: HUZI0609
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2015
• 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: 53 YR
• Patient Sex: Male