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

Catalog Number	0115810
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Injury (2348); Disability (2371)
Date of Event	02/09/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges injuries; however, no details have been provided regarding the nature of the injury.No lot number has been provided; therefore a review of the manufacturing records is not possible.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: on (b)(6) 2007: the patient underwent surgery for implant of an unspecified bard/davol modified kugel.On (b)(6) 2011: the patient had unspecified injuries.The patient is making a claim for an adverse patient outcome against the modified kugel.The patient's 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.".
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2007: the patient underwent surgery for implant of an unspecified bard/davol modified kugel.(b)(6) 2011: the patient had unspecified injuries.The patient is making a claim for an adverse patient outcome against the modified kugel.The patient's 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) 2007 - patient was diagnosed with bilateral inguinal hernia thereby underwent open repair with the implant of two modified kugel patch (device #1 - left, device #2 - right).Per operative notes, ¿on the left, the patient had a large direct inguinal hernia.The hernia sac was reduced back down into the abdominal cavity.A barred modified kugel patch (device #1) was placed in the pre-peritoneal space.The onlay piece was then placed down onto the inguinal floor, and sutured inferior medially to the conjoined tendon, and the pubic tubercle, and laterally to the inguinal ligament.On the right side, the patient had a larger direct hernia which was repaired as same as left side, using modified kugel patch (device #2).¿ (b)(6) 2010 - patient had ilioinguinal nerve block.(b)(6) 2011 - patient was diagnosed with bilateral ilioinguinal neuropathy and bilateral groin pain thereby underwent open repair.Per operative notes, ¿on right side, the ilioinguinal nerve was coming out of the external inguinal ring and entrapped in scar tissue was dissected.The previously placed mesh (device #2) was directly beneath the external oblique aponeurosis and nerve entrapped in scarring underneath the mesh was dissected.On left groin side, the nerve was trapped in scar tissue were divided and suture ligated.There were a large vein in space beneath the external oblique aponeurosis were adherent to the mesh (device #1).¿ attorney alleged that the patient had nerve damage, pain, hernia recurrence and emotional injuries.It is also alleged that the patient had constant extensive groin pain after the first surgery and it was very hard for him to bend over and per surgery dated (b)(6) 2011 "the previous mesh was directly beneath the external oblique aponeurosis and the nerve was entrapped in some scarring underneath the mesh." during surgery, patient had very large veins adhered to the mesh and he began to bleed profusely.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges injuries; however, no details have been provided regarding the nature of the injury.No lot number has been provided; therefore a review of the manufacturing records is not possible.Addendum: this supplemental emdr is submitted to document additional information provided.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 3 years 6 month post implant of modified kugel patch, patient was diagnosed with nerve damage, pain, adhesion and scar tissue thereby underwent repair.The instructions-for-use supplied with the device list adhesion as a possible complication.This supplemental emdr represents the modified kugel patch (device #1).An additional emdr was submitted to represent the modified kugel patch (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: MODIFIED 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: 8166929
• Report Number: 1213643-2018-04799
• Device Sequence Number: 2792451
• Product Code: FTL
• UDI-Device Identifier: 00801741030796
• UDI-Public: (01)00801741030796
• 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: 2007
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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 Catalogue Number: 0115810
• Device Lot Number: 43EQD176
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 02/20/2025
• 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: Disability; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 86 KG