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

Catalog Number	0010103
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	08/30/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol kugel patch (device #1) used to treat the patient.The patient's attorney did allege injuries; 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.This emdr represents the bard/davol kugel patch (device #1).An additional emdr was submitted to represent the bard/davol composix kugel (device #2).Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol kugel hernia patch (device #1) on (b)(6) 2010.It is alleged that on (b)(6) 2010 the patient had unspecified injuries and underwent surgery with implant of an unspecified bard/davol composix kugel hernia patch (device #2).It is alleged the patient had unspecified injuries and underwent revision surgery on (b)(6) 2012.As reported, the patient is making a claim for an adverse patient outcome against the bard/davol kugel hernia patch and composix kugel hernia patch.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.".
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol kugel hernia patch (device #1) on (b)(6) 2010.It is alleged that on (b)(6) 2010 the patient had unspecified injuries and underwent surgery with implant of an unspecified bard/davol composix kugel hernia patch (device #2).It is alleged the patient had unspecified injuries and underwent revision surgery on (b)(6) 2012.As reported, the patient is making a claim for an adverse patient outcome against the bard/davol kugel hernia patch and composix kugel hernia patch.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) 2010 - patient was diagnosed with small bowel obstruction and incisional hernia thereby underwent open repair with the implant of kugel patch (device #1).Per operative notes, "the hernia sac was dissected out and opened.A large hernia noted on right side was reduced.A kugel patch (device #1) was placed and sutured." (b)(6) 2010 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair partial removal of mesh (device #1) and implant of composix kugel mesh (device #2).Per operative notes, "the hernia sac was opened.The piece of mesh (device #1) had been ripped off the right side the fascial defect was removed.A large defect in the upper abdomen was noted.A composix kugel mesh (device #2) was sutured." (b)(6) 2012 - patient was diagnosed with recurrent ventral hernia thereby underwent lysis of adhesion, component separation and removal of mesh.Per operative notes, "the hernia sac located at subdermal at the cephalad portion of dissection.The old mesh (device #2) was removed.The majority of retained unincorporated mesh was debrided." (b)(6) 2013 - patient was diagnosed with recurrent incisional hernia thereby underwent removal of mesh and lysis of adhesion.Per operative notes, "the retained mesh was removed.A synthetic mesh was placed and sutured.".
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol kugel patch (device #1) used to treat the patient.The patient's attorney did allege injuries; 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.This emdr represents the bard/davol kugel patch (device #1).An additional emdr was submitted to represent the bard/davol composix kugel (device #2).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.This supplemental emdr represents the bard/davol kugel patch (device #1).An additional supplemental emdr was submitted to represent the bard/davol composix kugel (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.

• Brand Name: 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: 8541778
• Report Number: 1213643-2019-03316
• Device Sequence Number: 11377050
• Product Code: FTL
• UDI-Device Identifier: 00801741016356
• UDI-Public: (01)00801741016356
• 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: 2010
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

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: 0010103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 06/05/2025
• 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: Disability; Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male