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

Catalog Number	0115810
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348)
Date of Event	04/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cause of the patient's post-op complications cannot be determined at this time.The patient's attorney alleges unspecified injuries and surgery; however, no details have been provided regarding the nature of the injury or surgery.No medical records have been provided.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.No sample returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2007: the patient underwent surgery for implant of an unspecified bard/davol modified kugel hernia patch.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the patient is making a claim for an adverse patient outcome against the modified kugel hernia patch.As reported, the attorney alleges product is defective and that the patient experienced emotional distress.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2007: the patient underwent surgery for implant of an unspecified bard/davol modified kugel hernia patch.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the patient is making a claim for an adverse patient outcome against the modified kugel hernia patch.As reported, the attorney alleges product is defective and that the patient experienced emotional distress.Addendum per additional information provided: (b)(6) 2007 - patient was diagnosed with left inguinal hernia and lipoma of spermatic cord thereby underwent open repair with the implant of modified kugel hernia patch.Per operative notes, ¿small direct defect on the medial aspect of the floor was identified and excess hernia sac was removed.A modified kugel patch was placed through the internal ring into the preperitoneal space and secured by sutures.¿ (b)(6) 2018 - patient was diagnosed with adhesions thereby underwent laparoscopic repair.Per operative notes, ¿all bowel and tissue adhesions were taken down.¿ (b)(6) 2018 - patient was diagnosed with recurrent left groin hernia and pain thereby underwent open repair.Per operative notes, ¿previously placed mesh was identified, and the cord structures were densely adherent was separated.¿.
Additional Manufacturer Narrative
The cause of the patient's post-op complications cannot be determined at this time.The patient's attorney alleges unspecified injuries and surgery; however, no details have been provided regarding the nature of the injury or surgery.No medical records have been provided.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.Addendum: this supplemental emdr is submitted to document additional information provided.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: 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: 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: 8412923
• Report Number: 1213643-2019-01615
• Device Sequence Number: 1795349
• Product Code: FTL
• UDI-Device Identifier: 00801741030796
• UDI-Public: (01)00801741030796
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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 Catalogue Number: 0115810
• Device Lot Number: 43EQD172
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 58 YR
• Patient Sex: Male