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

Catalog Number	0010105
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Insufficient Information (4580)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.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.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 the implant of unspecified bard mesh (bard flat mesh) and bard/davol kugel hernia patch.As reported, the patient is making a claim for an adverse patient outcome against kugel hernia patch which was implanted on (b)(6) 2016.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 the implant of unspecified bard mesh (bard flat mesh) and bard/davol kugel hernia patch.As reported, the patient is making a claim for an adverse patient outcome against kugel hernia patch which was implanted on (b)(6) 2016.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: (b)(6) 2016 ¿ patient was diagnosed with incisional ventral hernia thereby underwent open repair with the implant of kugel patch (device #1).Per op notes, ¿a small bowel herniation which was incarcerated into the hernia sac was noted.The kugel patch(device #1) was placed in the underlay fashion in the sub internal oblique position covering the hernia defect and sutured.¿ (b)(6) 2020 ¿ patient was diagnosed with recurrent incisional ventral hernia thereby underwent robotic repair with the implant of bard flat mesh (device #2).Per op notes, ¿the hernia defect was identified.The adhesiolysis were done.An old piece of mesh (device #1) was left in situ, which appeared to be well incorporated.The bard flat mesh (device #2) was placed inside the abdomen and secured to cooper¿s ligament using sutures.¿.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.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: 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: 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: 12074929
• Report Number: 1213643-2021-05267
• Device Sequence Number: 17042260
• Product Code: FTL
• UDI-Device Identifier: 00801741016370
• UDI-Public: (01)00801741016370
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 06/12/2025

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: 0010105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 06/12/2025
• 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: 63 YR
• Patient Sex: Male