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

Catalog Number	0010101
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	08/23/2011
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 kugel patch (device 2).An additional supplemental emdr was submitted to represent the kugel patch (device 1).Additional mdrs were submitted to represent the kugel patches (3,4).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) 2007 - patient was diagnosed with left indirect with direct attenuation and right direct inguinal hernia thereby underwent open repair with implant of kugel patch (device 1 and 2) in the left and (device 3 and 4) in the right.Per op notes, ¿a left transverse inguinal incision was made.An indirect hernia sac was identified and noted a loop of sigmoid colon adherent to it was taken down.And the hernia sac was ligated.A kugel patch (device 1 and 2) were placed in the preperitoneal space and secured with suture.A right inguinal incision was made and a direct right inguinal hernia was identified.A kugel patch (device 3 and 4) were placed and secured with suture.¿ on (b)(6) 2011 - patient was diagnosed with bilateral recurrent inguinal hernias thereby underwent laparoscopic repair with implant of synthetic mesh x2.Per op notes, ¿a transverse incision was made.The left recurrent inguinal hernia mesh (device 1 and 2) was dissected from the anterior abdominal wall.A significant adhesion of small bowel to the mesh (device 1 and 2) was noted and this was left intact.A synthetic mesh was placed and secured to cooper¿s ligament.The old mesh (device 1 and 2) was then placed over this synthetic mesh and tacked to the anterior abdominal wall.A right recurrent indirect inguinal hernia was noted with significant adhesions and old mesh (device 3 and 4).A synthetic mesh was placed over the indirect defect and secured with tacks.¿.

• 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: 24337140
• Report Number: 1213643-2026-00141
• Device Sequence Number: 18589589
• Product Code: FTL
• UDI-Device Identifier: 00801741016332
• UDI-Public: (01)00801741016332(10)43FQD336
• 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: 2007
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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: 0010101
• Device Lot Number: 43FQD336
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/13/2026
• 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: 70 YR
• Patient Sex: Male