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); Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Pain (1994); Hernia (2240); Disability (2371)
Date of Event	02/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Currently, it is unknown whether the device may have caused or contributed to the reported event as no specific device failure or patient injury was alleged.To date no medical records have been provided.With the current information available, no definitive conclusion can be made.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: on (b)(6) 2012 - the patient underwent surgery for repair of an incisional hernia.The patient's hernia was repaired with a kugel patch.On (b)(6) 2017 - the patient underwent an additional surgery to remove the previously placed kugel mesh which allegedly failed.The attorney alleges the patient has suffered physical pain and was injured severely and permanently.
Additional Manufacturer Narrative
Addendum to the previous report.This supplemental emdr is being sent to provide the correct manufacture and expiration date for the kugel patch.With the current information available, no definitive conclusion can be made.If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.
Event or Problem Description
The following was reported to davol by the patient's attorney: (b)(6) 2012 - the patient underwent surgery for repair of an incisional hernia.The patient's hernia was repaired with a kugel patch.(b)(6) 2017 - the patient underwent an additional surgery to remove the previously placed kugel mesh which allegedly failed.The attorney alleges the patient has suffered physical pain and was injured severely and permanently.
Additional Manufacturer Narrative
Currently, it is unknown whether the device may have caused or contributed to the reported event as no specific device failure or patient injury was alleged.To date no medical records have been provided.With the current information available, no definitive conclusion can be made.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Addendum #1: this supplemental emdr is being sent to provide the correct manufacture and expiration date for the kugel hernia patch.With the current information available no definitive conclusion can be made.If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.Addendum #2: this supplemental mdr 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 the medical records review, post implant of kugel hernia patch patient was diagnosed with pain, adhesion and underwent mesh removal.The instructions-for-use supplied with the device identify adhesions as a possible complication.Review of manufacturing records confirms product was manufactured to specification.This emdr represents the bard/davol kugel patch (device #1).An additional emdr was submitted to represent the bard/davol composix kugel mesh (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.H3 other text: not returned.
Event or Problem Description
Per legal complaint no.: (b)(4).It is alleged by the patients attorney that on (b)(6) 2012, the patient underwent surgery for repair of an incisional hernia.As reported, the patients hernia was repaired with a bard/davol small circle kugel patch, reference number 0010103, lot number huvc2222.It is alleged that several years later, on (b)(6) 2017, the patient underwent an additional surgery to remove the previously placed kugel mesh.It is alleged the patient endured additional surgeries to treat mesh-related complications.As reported, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective kugel patch.Addendum per additional information: on (b)(6) 2012, patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with implant of kugel hernia patch (device #1) and composix kugel (device #2).Per operative notes, "the preperitoneal fat in the incisional umbilical hernia was reduced.A small oval composix kugel mesh (device #2) was passed into the abdominal cavity.The peritoneum in the right lower quadrant was incised and the defect was identified.A small kugel circle mesh (device #1) was placed".On (b)(6) 2015, patient underwent diagnostic laparoscopy and lysis of adhesions.Per operative notes "once freed the abdominal wall adhesions, there was no hernia.Previous staples in the right lower quadrant, anterior abdominal wall from previous surgery as well as mesh was in place".On (b)(6) 2017, patient had right lower quadrant pain and underwent total abdominal hysterectomy with partial mesh explant.Per operative notes, "on the right lower quadrant palpated, there was mass like effect.As the mesh product was excised, a dense circumferential ring of a plastic material was encountered.The mesh (device #1) and the plastic ring were excised.On (b)(6) 2018, patient underwent exploratory laparotomy with removal of meshes (device #1 & device #2) and repair of recurrent ventral hernia.Per operative notes, "appeared to be a recurrent hernia in periumbilical which included incarcerated fat and was resected.Performed adhesiolysis from the mesh that was at her umbilicus.This mesh was removed.The patient also had a mesh, which was placed somewhat preperitoneal on the right side and was completely resected.This mesh was densely ingrown into the fascia.We then used a biological mesh".Attorney alleges that the patient had adhesions, mesh migration, mesh shrinkage, fistula, pain, underwent lysis of adhesions on (b)(6) 2015 and emotional injuries.

• 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: 7011704
• Report Number: 1213643-2017-00814
• Device Sequence Number: 10868540
• 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: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2023

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: 04/28/2016
• Device Model Number: 0010103
• Device Catalogue Number: 0010103
• Device Lot Number: HUVC2222
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 07/06/2018; 06/05/2023
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 07/10/2018; 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2011
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 97 KG