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

Catalog Number	0010105
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	11/05/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's 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; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol kugel hernia patch (device #2).An additional emdr was submitted to represent the bard/davol composix kugel hernia patch (device #1).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 an unspecified bard/davol composix kugel hernia patch on (b)(6) 2008 and a kugel hernia patch on (b)(6) 2008.As reported, the patient is making a claim for an adverse patient outcome against both devices.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." 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 an unspecified bard/davol composix kugel hernia patch on (b)(6) 2008 and a kugel hernia patch on (b)(6) 2008.As reported, the patient is making a claim for an adverse patient outcome against both devices.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." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: on (b)(6) 2008, patient was diagnosed with large direct left inguinal hernia thereby underwent open repair with the implant of composix kugel patch (device #1).Per operative notes, "a large direct defect was noted, the hernia was completely reduced and dissection was extended.A composix kugel patch (device #1) was placed within the preperitoneal space with patch placed deep into inguinal ligament and sutured." on (b)(6) 2008, patient was diagnosed with large direct right inguinal hernia thereby underwent open repair with the implant of kugel hernia patch (device #2).Per operative notes, " a large direct fascial defect was noted and the hernia was completely reduced.A pocket was created and a kugel hernia patch (device #2) was placed covering the floor of the inguinal region.The patch was laid flat." on (b)(6) 2011, patient was diagnosed with recurrent indirect left inguinal hernia thereby underwent open repair.Per operative notes, "a large hernia sac accompanying with cord structures was noted.The previously placed inferior margin of mesh (device #1) was identified and the ilioinguinal ligament was cleared.The mesh was tacked to the ligament with sutures.The facial defect was closed." on (b)(6) 2012, patient was diagnosed with recurrent direct right inguinal hernia thereby underwent open repair.Per operative notes, "the floor of inguinal canal was inspected and the inferior edge of mesh (device #2) was identified.Hernia was developed in the inferior margin of mesh.The hernia sac was protruding under the mesh.The mesh (device #2) was tacked to the inguinal ligament with sutures.".
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's 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; 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.Updated fields: a2, b2, b3, b4, b5, b7, d3, d4 (catalog no, lot no, udi), g3, g6, h2, h6, h10.This supplemental emdr represents the bard/davol kugel hernia patch (device #2).An additional supplemental emdr was submitted to represent the bard/davol composix kugel hernia patch (device #1).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.H3 other text: not returned.

• 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: 9530483
• Report Number: 1213643-2019-12571
• Device Sequence Number: 388210
• Product Code: FTL
• UDI-Device Identifier: 00801741016370
• UDI-Public: (01)00801741016370(10)43DPD272
• 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: 2008
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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
• Device Lot Number: 43DPD272
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 06/30/2025
• 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: 69 YR
• Patient Sex: Male