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

Catalog Number	0115816
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Injury (2348); Disability (2371)
Date of Event	04/11/2014
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.No lot number has been provided therefore a review of the manufacturing records is not possible.This emdr represents the bard/davol kugel patch (device #1).An additional emdr was submitted to represent the bard/davol ventrio st (device #2).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 kugel hernia patch (device #1) and an unspecified bard/davol ventrio st (device #2) on (b)(6) 2013.As reported, the patient is making a claim for an adverse patient outcome against the kugel hernia patch (device #1) and the ventrio st (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.".
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol kugel patch (device 1) used to treat the patient.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 the brand name 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-oct-2013) is considered to be a best estimate.Updated fields: a2, a4, b2, b3, b4, b5, b7,d3, d4 (product catalog no., udi no., expiry date, corporate lot no.), d6b (date of explant), g1, g3, g6, h2, h4, h6, h10, h11.Corrected field: d1 (brand name).This supplemental emdr represents the bard/davol¿modified kugel patch (device 1).An additional supplemental emdr was submitted to represent the bard/davol - ventrio st (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.H3 other text: 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) and an unspecified bard/davol ventrio st (device 2) on (b)(6) 2013.As reported, the patient is making a claim for an adverse patient outcome against the kugel hernia patch (device 1) and the ventrio st (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) 2013 - patient was diagnosed with ventral incisional hernia thereby underwent open repair with implant of modified kugel patch.Per operative notes, ¿the complex hernia sac was dissected to the level of fascia and excised.They were converted into solitary defect and modified kugel patch was placed in the peritoneal cavity tacked and sutured.¿ (b)(6) 2014 - patient had adhesion and pain thereby underwent open repair with removal of previously placed mesh.Per operative notes, ¿the previously placed mesh was excised and omental adhesions to this mass was removed and fascia was closed with sutures.¿.

• 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: 8842831
• Report Number: 1213643-2019-06439
• Device Sequence Number: 16215731
• Product Code: FTL
• UDI-Device Identifier: 00801741030826
• UDI-Public: (01)00801741030826(17)181028(10)HUXJ0186
• 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: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: 10/28/2018
• Device Catalogue Number: 0115816
• Device Lot Number: HUXJ0186
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2013
• 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: Disability; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 171 KG