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

Catalog Number	0010101
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	09/23/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6)2004 - patient was diagnosed with bilateral direct inguinal hernias and cord lipomas thereby underwent open repair with the implant of kugel patch (right - device #1 & left - device #2).Per operative notes, ¿in the right inguinal region, a small right cord lipoma was resected and a kugel patch (right - device #1) was placed and sutured.In left inguinal region, large left direct hernia including a small cord lipoma was resected and a kugel patch (left - device #2) was placed and sutured.¿ (b)(6)2006 - patient was diagnosed with recurrent bilateral direct inguinal hernias thereby underwent repair with the implant of kugel patch (right - device #3 & left - device #4).(note, there was no implant op notes provided).(b)(6)2011 - patient was diagnosed with recurrent left femoral hernia thereby underwent open repair with the implant of perfix plug (device #5) and explant of kugel patch (left - device #2 & #4).Per operative notes, ¿the previously placed kugel patch (left - device #2 & #4) had migrated inferiorly at femoral region which was dissected away and removed.The hernia sac was dissected and a perfix plug (device #5) was placed into the femoral ring and sutured.¿ (b)(6)2011 - patient was diagnosed with symptomatic reducible right femoral hernia thereby underwent open repair with the implant of perfix plug (device #6).Per operative notes, ¿the femoral hernia sac was dissected and reduced back into a preperitoneal position and a perfix plug (device #6) was fashioned to fit into the femoral canal and secured superiorly or anteriorly to the ilioinguinal ligament and previously placed kugel patch (right - device #1 & #3).¿ attorney alleges that the patient had bowel perforation, revision surgery, pain, hernia recurrence and emotional injuries.
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 7 years 6 months post implant of kugel patch, patient was diagnosed with hernia recurrence and mesh migration thereby underwent repair with mesh removal.The instructions-for-use supplied with the device lists hernia recurrence as a possible complication.This emdr represents kugel patch (device #2).An additional supplemental emdr was submitted to represent kugel patch (device #1) and additional emdr's were submitted to represent kugel patch (device #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.

• Brand Name: KUGEL PATCH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: 20876504
• Report Number: 1213643-2024-094849
• Device Sequence Number: 8928916
• Product Code: FTL
• UDI-Device Identifier: 00801741016332
• UDI-Public: (01)00801741016332
• 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: 2004
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2024

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: 43AOD194
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 52 KG