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

Model Number	0115814
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240); Disability (2371); Fibrosis (3167)
Date of Event	02/11/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event.To date no medical records have been provided.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.The information provided by bard 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 bard.
Event or Problem Description
The following was reported to davol by the patient's attorney: on (b)(6) 2009 - the patient underwent a surgery for a left inguinal hernia, a tension-free modified kugel patch was implanted to repair the hernia.On (b)(6) 2015 - the patient underwent surgery for the removal of his kugel patch.During the procedure, it is alleged the surgeon noted extensive fibrosis and "entrapment of the posterior margin of the cord onto the underlying mesh." the attorney alleges the patient has suffered and will continue to suffer pain and was seriously and permanently injured.
Additional Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event.To date no medical records have been provided.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Addendum: this supplemental emdr is submitted to document additional information provided.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical record review, about 5 years 1 month post implant of the modified kugel patch, patient had hernia recurrence, fibrosis thereby underwent repair with mesh removal.Per op notes, "mesh did appear to penetrate into the preperitoneal space." the instructions-for-use supplied with the device list hernia recurrence as a possible complication.Review of manufacturing records confirms product was manufactured to specification.
Event or Problem Description
The following was reported to davol by the patient's attorney: (b)(6) 2009 - the patient underwent a surgery for a left inguinal hernia, a tension-free modified kugel patch was implanted to repair the hernia.(b)(6) 2015 - the patient underwent surgery for the removal of his kugel patch.During the procedure, it is alleged the surgeon noted extensive fibrosis and "entrapment of the posterior margin of the cord onto the underlying mesh." the attorney alleges the patient has suffered and will continue to suffer pain and was seriously and permanently injured.Addendum per additional information provided: (b)(6) 2009 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with the implant of modified kugel patch (device #1).Per operative notes, "a large direct hernia was identified.Bowel was encountered within the hernia sac.The preperitoneal space was bluntly dissected.A modified kugel patch (device #1) was then placed in the preperitoneal space.An onlay mesh was placed over the anterior inguinal floor and sutured." (b)(6) 2015 - patient was diagnosed with recurrent left inguinal hernia and underwent open repair with mesh removal (device #1) and implanted with bard soft mesh (device #2).Per operative notes, "there was extensive fibrosis and entrapment of posterior margin of the cord onto an underlying nylon type mesh in the preperitoneal space as well as expanding as an onlay (device #1).Mesh did appear to penetrate into the preperitoneal space.The large indirect hernia sac was dissected.The mesh was loosened and dissected off from the attachments (device #1).The preperitoneal space was palpated and there may have been a portion of the plug left, although it appeared fairly deep and was overlying the femoral vessels.Decided not to attempt to completely dissect the preperitoneal space and attempt to explant any remnant of the plug (device #1).Reconstruction of floor was fashioned with a wide pore soft mesh (device #2)." attorney alleges that the patient had hernia recurrence, mesh migration, extensive fibrosis, entrapment of the cord, pain and emotional injuries.

• 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: 7070547
• Report Number: 1213643-2017-00951
• Device Sequence Number: 13704192
• Product Code: FTL
• UDI-Device Identifier: 00801741030819
• UDI-Public: (01)00801741030819
• 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: 2009
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2023

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 Expiration Date: 01/28/2014
• Device Model Number: 0115814
• Device Catalogue Number: 0115814
• Device Lot Number: HUSL1180
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2009
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 72 KG