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

Catalog Number	0115812
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	02/21/2014
Type of Reportable Event	Serious Injury
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 mdr represents the modified kugel hernia patch (device 2).Additional supplemental emdr¿s were submitted to represent the modified kugel hernia patch (device 1) and bard flat mesh (device 3).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.
Event or Problem Description
Per information provided: on (b)(6) 2011 - patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with implant of modified kugel hernia patch (device 1 and 2).Per op notes, ¿on the right inguinal region, a large direct hernia defect was noted with bowel contents in scrotum were reduced.A modified kugel hernia patch (device 1) was placed and sutured.On the left inguinal region, a direct hernia defect was noted and reduced.A modified kugel hernia patch (device 2) was placed and sutured¿.On (b)(6) 2014 - patient was diagnosed with recurrent left inguinal hernia thereby underwent laparoscopic repair with excision of modified kugel hernia patch (device 2) and implant of bard flat mesh (device 3).Per op notes, ¿the previous mesh (device 2) was stuck in incision site and curled up and not covering the defect.A new defect was identified over this.The hernia sac was reduced.The prior mesh (device 2) was excised.A bard flat mesh (device 3) was placed and tacked.¿ on (b)(6) 2017 - patient was diagnosed with adhesions and mesh protrusion on right groin thereby underwent laparoscopic repair with excision of modified kugel hernia patch (device 1).Per op notes, ¿the old mesh (device 1) on the right groin was protruded into abdominal cavity and stuck in the bowel.The old mesh densely adherent to bowel was taken down.The mesh stuck in the bowel was separated.The old mesh (device 1) was excised and sutured.¿.

• 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 ; 8005566756
• MDR Report Key: 24469926
• Report Number: 1213643-2026-00254
• Device Sequence Number: 18707663
• Product Code: FTL
• UDI-Device Identifier: 00801741030802
• UDI-Public: (01)00801741030802(10)43EQD182
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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: 0115812
• Device Lot Number: 43EQD182
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 02/27/2026
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 68 KG