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

Catalog Number	0010103
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	03/25/2016
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.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.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Based on the limited information provided at this time, no conclusions can be made.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: on (b)(6) 2009: the patient underwent a surgery to repair a right inguinal hernia.As reported, the patient's hernia was repaired with a bard/davol kugel patch.On (b)(6) 2016: the patient underwent surgery to repair recurrent right inguinal hernia.As alleged, the patient was seriously and permanently injured and has suffered and will continue to suffer physical pain due to the alleged defective kugel patch.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2009: the patient underwent a surgery to repair a right inguinal hernia.As reported, the patient's hernia was repaired with a bard/davol kugel patch.(b)(6) 2016: the patient underwent surgery to repair recurrent right inguinal hernia.As alleged, the patient was seriously and permanently injured and has suffered and will continue to suffer physical pain due to the alleged defective kugel patch.Addendum per medical records: (b)(6) 2009 - patient was diagnosed with right inguinal hernia thereby underwent laparoscopic repair with the implant of kugel patch on (b)(6) 2009.Per operative notes, ¿the inguinal hernia defect was identified.A kugel mesh was inserted on the external side and secured with sutures.¿ (b)(6) 2016 - patient was diagnosed with recurrent right inguinal hernia thereby underwent laparoscopic repair.Per operative notes, ¿a recurrent right inguinal hernia was identified and the previous mesh was found with scarring.The hernia sac was reduced, fascia fully exposed to allow placement of mesh.A piece of polypropylene mesh was cut to fit the defect and secured with tackers.¿ attorney alleges that the patient had mesh migration, ring break, hernia recurrence and emotional injuries.
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.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.No lot number has been provided; therefore, a review of the manufacturing records is not possible at this time.Based on the limited information provided at this time, no conclusions can be made.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 6 years 4 months post implant of kugel patch, patient was diagnosed with hernia recurrence and scarring thereby underwent repair.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Updated fields: a2, a4, b4, b5, b7, d4, e3, g1, g3, g6, h2, h4, h6, h10.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.

• 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: 7249522
• Report Number: 1213643-2018-00227
• Device Sequence Number: 1035689
• 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: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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: 06/28/2014
• Device Catalogue Number: 0010103
• Device Lot Number: HUTE1479
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2009
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 82 KG