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	Pain (1994); Scar Tissue (2060); Hernia (2240); Disability (2371)
Date of Event	10/23/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient.The patient's attorney did not allege a specific device failure and no medical records have been provided.Based on the limited information provided at this time, no conclusions can be made.Recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.Should additional information be provided a supplemental emdr 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.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2011: the patient underwent an abdominal surgery for an inguinal hernia.The patient's hernia was repaired with a bard/davol kugel patch, (b)(4), lot number huud0491.(b)(6) 2013: the patient underwent surgery to have a recurrence repair.As alleged, the patient has suffered and will continue to suffer physical pain due to the alleged defective kugel patch.
Additional Manufacturer Narrative
Addendum to the previous information.This supplemental emdr is being sent to update the brand name of the device used.A manufacturing review was conducted which found that the device provided was manufactured to specification.With the current information available no definitive conclusion can be made.If additional event and/or evaluation information is obtained, this report will be updated.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2011: the patient underwent an abdominal surgery for an inguinal hernia.The patient's hernia was repaired with a bard/davol (modified) kugel patch, product code 0115810, lot number huud0491.(b)(6) 2013: the patient underwent surgery to have a recurrence repair.As alleged, the patient has suffered and will continue to suffer physical pain and was injured severely and permanently due to the alleged defective (modified) kugel patch.
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient.The patient's attorney did not allege a specific device failure and no medical records have been provided.Based on the limited information provided at this time, no conclusions can be made.Recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.Addendum #1: addendum to the previous information.This supplemental emdr is being sent to update the brand name of the device used.A manufacturing review was conducted which found that the device provided was manufactured to specification.With the current information available no definitive conclusion can be made.If additional event and/or evaluation information is obtained, this report will be updated.Addendum #2: this supplemental emdr is submitted to document additional information provided.Based on the available information, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 2 years 9 months post implant of modified kugel mesh, patient was diagnosed with hernia recurrence, scar tissue and pain.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
The following was alleged by the patient's attorney: (b)(6) 2011: the patient underwent an abdominal surgery for an inguinal hernia.The patient's hernia was repaired with a bard/davol kugel patch, product code 0115810, lot number huud0491.(b)(6) 2013: the patient underwent surgery to have a recurrence repair.As alleged, the patient has suffered and will continue to suffer physical pain due to the alleged defective kugel patch.Addendum per additional information: (b)(6) 2011 - patient was diagnosed with left inguinal hernia thereby underwent open repair with the implant of modified kugel patch.Per operative notes, "the hernia sac was reduced into the intraperitoneal cavity.A modified kugel mesh was placed within the preperitoneal space and sutured.¿ (b)(6) 2013 - patient was diagnosed with recurrent left inguinal hernia thereby underwent repair the implant of synthetic mesh.Per operative notes, "there was some scarring from previous surgery.A very large indirect hernia sac was found and dissected.A synthetic mesh was placed and sutured.¿ (note: there was no mention/visualization of the modified kugel patch).(b)(6) 2014 - patient visited hospital for pain.Attorney alleged that the patient had abscess, hernia recurrence, infection, 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: 7175405
• Report Number: 1213643-2018-00036
• Device Sequence Number: 1888434
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2024

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 Expiration Date: 04/28/2015
• Device Catalogue Number: 0115810
• Device Lot Number: HUUD0491
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 05/17/2018; 12/19/2023
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 05/18/2018; 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2010
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 64 KG