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); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Disability (2371)
Date of Event	05/01/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol kugel patch (device #2) may have caused or contributed to the reported event.The attorney alleges that the patient had unspecified injuries; however, no details have been provided.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol kugel patch (device #2).An additional emdr was submitted to represent the bard/davol composix kugel (device #1).There is no allegation related to the bard/davol soft mesh.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol composix kugel hernia patch (device #1) on (b)(6) 2007, an unspecified bard/davol kugel hernia patch (device #2) on (b)(6) 2010 and an unspecified bard/davol bard soft mesh on (b)(6) 2013.It is also alleged by patient attorney that on (b)(6) 2009, the patient had unspecified injuries.As reported, the patient is making a claim for an adverse patient outcome against the composix kugel hernia patch (device #1) and the kugel hernia patch (device #2).As reported, 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 composix kugel hernia patch (device #1) on (b)(6) 2007, an unspecified bard/davol kugel hernia patch (device #2) on (b)(6) 2010 and an unspecified bard/davol bard soft mesh on (b)(6) 2013.It is also alleged by patient attorney that on (b)(6) 2009, the patient had unspecified injuries.As reported, the patient is making a claim for an adverse patient outcome against the composix kugel hernia patch (device #1) and the kugel hernia patch (device #2).As reported, 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) 2007 - patient was diagnosed with incarcerated ventral anterior abdominal hernia with incarcerated omentum thereby underwent open repair with the implant of composix kugel mesh (device #1).Per operative notes, "the hernia sac was opened with incarcerated omental fat.The final defect was noted and a composix kugel mesh (device #1) was placed and sutured." (b)(6) 2009 - patient was diagnosed with incarcerated recurrent ventral hernia thereby underwent open repair with the removal of migrated mesh (device #1) and implant of mesh.Per operative notes, "the mesh (device #1) was away off the right lateral border of abdominal wall.The bowel was densely adhered to the mesh.The mesh was removed." (b)(6) 2010 - patient was diagnosed with ventral abdominal incisional hernia thereby underwent open repair with the implant of kugel hernia patch (device #2, #3).Per operative notes, "the hernia sac was excised, the prior sutures were noted and removed.Two pieces of kugel patch was placed, one on right placed transversely across midline.One on left side vertically crossing the midline.".
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol kugel patch (device #2) may have caused or contributed to the reported event.The attorney alleges that the patient had unspecified injuries; however, no details have been provided.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol kugel patch (device #2).An additional emdr was submitted to represent the bard/davol composix kugel (device #1).There is no allegation related to the bard/davol soft mesh.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, the manufacturing date (15-jun-2010) is considered to be a best estimate.This supplemental emdr represents the bard/davol kugel patch (device #2).An additional supplemental emdr was submitted to represent the bard/davol composix kugel (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.

• 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: 9484011
• Report Number: 1213643-2019-12267
• Device Sequence Number: 14116118
• Product Code: FTL
• UDI-Device Identifier: 00801741016370
• UDI-Public: (01)00801741016370(17)150628(10)HUUF0726
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: 06/28/2015
• Device Catalogue Number: 0010105
• Device Lot Number: HUUF0726
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2010
• 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
• Patient Age: 49 YR
• Patient Sex: Female