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); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348)
Date of Event	05/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.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 3dmax mesh and modified kugel hernia patch.As reported, the patient is making a claim for an adverse patient outcome against the modified kugel hernia patch which was implanted on (b)(6) 2013.Attorney 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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol 3dmax mesh and modified kugel hernia patch.As reported, the patient is making a claim for an adverse patient outcome against the modified kugel hernia patch which was implanted on (b)(6) 2013.Attorney 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: on (b)(6) 2013 - patient was diagnosed with left inguinal indirect hernia thereby underwent open repair with implant of modified kugel patch (device #1).Per operative notes, ¿the hernia sac was identified and reduced.The modified kugel patch was placed in the peritoneal space and sutured.¿ on (b)(6) 2017 - patient was diagnosed with incarcerated recurrent left inguinal hernia and left groin pain thereby underwent laparoscopic repair with implant of 3dmax mesh (device #2).Per operative notes, ¿the left inguinal hernia was identified.The mesh (device #1) was seen densely adhered to the urinary bladder and left intact.Then the 3dmax mesh (device #2) was placed and tacked.¿.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges 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 pma/510(k) # 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-apr-2013) is considered to be a best estimate.Updated fields: a2, b2,b3, b4, b5, b7,d3, d4,g3, g6, h2, h4, h6, h10, h11.Corrected fields: g4 (pma/510(k) #).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.H11: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: 9621303
• Report Number: 1213643-2020-00518
• Device Sequence Number: 11272839
• Product Code: FTL
• UDI-Device Identifier: 00801741030796
• UDI-Public: (01)00801741030796(17)180528(10)HUXD2383
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: 05/28/2018
• Device Catalogue Number: 0115810
• Device Lot Number: HUXD2383
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2013
• 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: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male