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

Catalog Number	0115808
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Scar Tissue (2060); Hernia (2240); Injury (2348)
Date of Event	04/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol modified kugel hernia patch (device #1).An additional emdr was submitted to represent the bard/davol ventralight st (device #2).Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol modified kugel hernia patch and ventralight st on (b)(6) 2018.As reported, the patient is making a claim for an adverse patient outcome against both devices.Attorney also alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the 510(k) number.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-jul-2015) is considered to be a best estimate.Updated fields: a2, b3, b4, b5, b7, d4 (product catalog no., corporate lot no., udi no., expiry date), d6.A (date of implant), d6.B (date of explant), g3, g6, h2, h4, h6, h10, h11.Corrected field: g4 (pma/510(k) #).This supplemental emdr represents the bard/davol modified kugel patch (device #1).An additional supplemental emdr was submitted to represent the bard/davol ventralight st (device #2).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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol modified kugel hernia patch and ventralight st on (b)(6) 2018 and/or (b)(6) 2018.As reported, the patient is making a claim for an adverse patient outcome against both devices.Attorney also alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2018 ¿ patient was diagnosed with incarcerated left inguinal hernia thereby underwent open repair with implant of modified kugel mesh (device #1).Per operative notes, ¿a modified kugel mesh (device #1) was placed into the defect and sewn using sutures.An onlay patch was sewn onto the pubic tubercle, shelving edge of the inguinal ligament as well as the transverse fascia using sutures.¿ (b)(6) 2018 ¿ patient was diagnosed with recurrent incarcerated left inguinal hernia thereby underwent robotic assisted repair with implant of ventralight st mesh (device #2).Per operative notes, ¿the hernia sac was reduced.A piece of ventralight st mesh (device #2) was placed into the defect and sewn using sutures.¿ (b)(6) 2019 ¿ patient was diagnosed with left inguinal hernia, thereby underwent open repair with the removal of mesh (device #1).Per operative notes, ¿scar tissue was noted.A piece of floating mesh (device #1) which was curled up was resected.A piece of ventralight st mesh (device #2) was found and it was all wadded up but straightened out again and laid flat and sutured.¿.

• Brand Name: MODIFIED 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 ; 4018258495
• MDR Report Key: 10141821
• Report Number: 1213643-2020-05691
• Device Sequence Number: 2464385
• Product Code: FTL
• UDI-Device Identifier: 00801741030789
• UDI-Public: (01)00801741030789(17)200728(10)HUZG1350
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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: 07/28/2020
• Device Catalogue Number: 0115808
• Device Lot Number: HUZG1350
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2015
• 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: 42 YR
• Patient Sex: Male