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

Catalog Number	0115810
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	05/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol modified kugel patch (device #1)may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol modified kugel patch (device #1).An additional emdr was submitted to represent the bard/davol (device #2).Note: not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2014: the patient underwent surgery for implant of two (2) unspecified bard/davol modified kugel patch (device#1 and device #2).The patient is only making a claim for an adverse patient outcome against the two (2) modified kugel hernia patch (device #1 and device #2).The attorney alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.¿.
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol modified kugel patch (device #1)may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited at this time.Addendum: this supplemental emdr is submitted to document additional information provided.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 3 years 1 month post implant of modified kugel patch, patient was diagnosed with hernia recurrence, pain and mesh migration thereby underwent repair with removal of mesh.The instructions-for-use supplied with the hernia recurrence as possible complication.The review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the manufacturing date (15-oct-2013) is considered to be a best estimate.This supplemental emdr represents the modified kugel patch (device #1).An additional supplemental emdr was submitted to represent the modified kugel patch (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
The following was alleged by the patient's attorney: (b)(6) 2014: the patient underwent surgery for implant of two (2) unspecified bard/davol modified kugel patch (device#1 and device #2).The patient is only making a claim for an adverse patient outcome against the two (2) modified kugel hernia patch(device #1 and device #2).The attorney alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.¿ addendum per additional information provided: (b)(6) 2014 - patient was diagnosed with bilateral inguinal hernia thereby underwent open repair with the implant of modified kugel patch (right side, device #1) and modified kugel patch (left side, device #2).Per operative notes, ¿indirect inguinal hernia was dissected from the peritoneal.Two modified kugel patch were deployed to the right, as well as left inguinal side and secure both mesh with suture.¿ (b)(6) 2016 - patient underwent ilioinguinal/iliohypogastric nerve block.(b)(6) 2017 - patient was diagnosed with recurrent right inguinal hernia thereby underwent laparoscopic repair with the explant of modified kugel patch (right side, device #1) and implant of synthetic mesh.Per operative notes, ¿the mesh had migrated.The mesh was carefully dissected.A synthetic mesh was placed into abdomen and secure it with suture.¿ attorney alleges that the patient had mesh migration, nerve damage, pain, hernia recurrence and emotional injuries.

• Brand Name: MODIFIED KUGEL PATCH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: 8147191
• Report Number: 1213643-2018-04517
• Device Sequence Number: 19339522
• Product Code: FTL
• UDI-Device Identifier: 00801741030796
• UDI-Public: (01)00801741030796(17)181028(10)HUXJ1026
• 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: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: 10/28/2018
• Device Catalogue Number: 0115810
• Device Lot Number: HUXJ1026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2013
• 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: Disability; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male