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

Model Number	0010103
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Disability (2371)
Date of Event	08/11/2015
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.Based on the information provided it is alleged the patient experienced hernia recurrence, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Not returned to manufacturer.
Event or Problem Description
The following was reported to davol by the patient's attorney: (b)(6) 2007 - the patient underwent surgery for the repair of an incarcerated right femoral hernia, a kugel patch was implanted to repair the hernia defect.(b)(6) 2015 - the patient underwent surgery for the removal of her failed kugel patch and the repair of her femoral hernia.During the operation, the physician noted that the kugel patch previously implanted had "rolled up." the kugel patch was dissected and removed.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.Based on the information provided it is alleged the patient experienced hernia recurrence, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.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 available information, there is no change to the initial determination, no conclusion can be made.Per the medical record review, about 7 years 10 months, post implant of kugel patch, patient was diagnosed with hernia recurrence and adhesions thereby underwent repair with the removal of mesh.Review of manufacturing records confirms product was manufactured to specification.Adhesions is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.
Event or Problem Description
The following was reported to davol by the patient's attorney: (b)(6) 2007 - the patient underwent surgery for the repair of an incarcerated right femoral hernia, a kugel patch was implanted to repair the hernia defect.(b)(6) 2015 - the patient underwent surgery for the removal of her failed kugel patch and the repair of her femoral hernia.During the operation, the physician noted that the kugel patch previously implanted had "rolled up." the kugel patch was dissected and removed.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) 2007 - patient was diagnosed with incarcerated recurrent right femoral hernia and umbilical hernia thereby underwent laparoscopic repair with the implant of kugel patch (device #1) and ventralex patch (device #2).Per operative notes, "the hernia sac was identified at the umbilical hernia defect, there was an incarcerated omentum within the femoral hernia and the previous right inguinal scar was dissected through the previous patch (non-bard/davol).A small round kugel patch (device #1) was placed in the preperitoneal space, covering the myopectineal orifice and femoral canal.Then the fascia was closed with a ventralex (device #2), impacted against the posterior abdominal wall, the gore-tex towards the abdominal viscera and sutured.¿ (b)(6) 2015 - patient was diagnosed with recurrent right large incarcerated femoral hernia thereby underwent repair with the removal of meshes (non-bard/davol & device #1).Per operative notes, "a femoral hernia was seen and the external oblique was then opened with great difficulty because there was an overlay mesh (device #1) was adherent to it.After tedious dissection, there was another mesh (non-bard/davol) was rolled up.Eventually both meshes (device #1 & non-bard/davol) and hernia sac were removed.(note: there was no mention/visualization of ventralex mesh).Attorney alleges that the patient had hernia recurrence, adhesions, pain and emotional injuries.It is also alleged that the mesh adhered to external oblique.

• 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: 7130849
• Report Number: 1213643-2017-01073
• Device Sequence Number: 1824561
• Product Code: FTL
• UDI-Device Identifier: 00801741016356
• UDI-Public: (01)00801741016356
• 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
• 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): 11/08/2023

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: 05/28/2012
• Device Model Number: 0010103
• Device Catalogue Number: 0010103
• Device Lot Number: HURD2712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2007
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 54 KG