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

Catalog Number	0010105
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Inflammation (1932); Hernia (2240); Fibrosis (3167)
Date of Event	05/10/2010
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2006 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with implant of kugel patch (device 1).Per op notes, "the old incision was opened.The mesh was noted to be bulged.It was opened and cut away.A medium kugel patch (device 1) was placed in the underside of the fascia and secured with suture.And the mesh which left was secured with suture." (note: the prior mesh visualized during this procedure was unknown).(b)(6) 2008 - patient was diagnosed with ventral hernia thereby underwent open repair with implant of ventralex mesh (device 2).Per op notes, "a transverse incision was made above the umbilicus.A fascial defect was identified on the left of the midline and no significant hernia sac was present.The sutures from the previous repair in the mesh were present and were removed.The omentum was adherent to the anterior abdominal wall around the fascial defect and was freed up.A large ventralex mesh (device 2) was placed into the defect and secured with sutures." (b)(6) 2010 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with excision of kugel patch (device 1) and ventralex mesh (device 2) and implant of synthetic mesh.Per op notes, "a transverse incision was made through the scar above the umbilicus.A fibrotic mass was noted above the fascia.The fascia was opened in the midline below the fibrotic area.Sutures from the old mesh were taken out.The mesh (device 1) was exposed.The reaction around the old mesh was thick.The area of fibrosis and old mesh (device 1) were removed.The scar tissue and mesh were excised.The teflon portion of the old ventralex mesh (device 2) was rolled up underneath the peritoneum and this was all removed.A synthetic mesh was placed beneath the fascia and secured with suture.".
Additional Manufacturer Narrative
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 emdr represents the kugel patch (device 1).An additional supplemental emdr was submitted to represent the ventralex mesh (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 ; 8005566756
• MDR Report Key: 25215616
• Report Number: 1213643-2026-00653
• Device Sequence Number: 9997964
• Product Code: FTL
• UDI-Device Identifier: 00801741016370
• UDI-Public: (01)00801741016370(10)43KPD365
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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: 43KPD365
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 46 YR
• Patient Sex: Female